Tenders Are Invited For Reagents And Consumables For A Modular Analyzer (Cobas 6000 С 501)

Cassette Iron Iron (Iron) For 200 Tests. Purpose: Kit For In Vitro Diagnostics. Intended For Quantitative Determination Of Iron In Serum And Plasma Of Human Blood On Roche/Hitachi Cobas C Analyzers. Reagents And Working Solutions: R1 Citric Acid: 200 Mmol/L; Thiourea: 115 Mmol/L; Detergent R3 Sodium Ascorbate 150 Mmol/L; Ferrozine: 6 Mmol/L; Preservative R1 Is Located In Position A, R3 - In Position B. Storage And Transportation Conditions: Store In A Refrigerator. Expiry Date At 2‑8°C See Expiry Date On Cobas C Kit Label. When Used Onboard The Analyzer At 10-15°C 6 Weeks. Transportation Must Be In Thermal Containers With Cooling Elements At A Temperature Of 2-8 °C, Do Not Expose To Freezing Or Exposure To High Temperatures. The Calibration Is Linear At Two Points, The Frequency Of Calibration Is After Changing The Lot. Measurement Range 0.9-179 Μmol/L (5-1000 Μg/Dl). The Lower Detection Limit Of The Test Is 0.9 Μmol/L (5.00 Μg/Dl). The Reproducibility Of The Test Is No More Than 1%. Reagents For The Cobas C 501 Analyzer. The Supplier Must Provide A Certificate Of Product Origin. The Scope Of Delivery Is For Eu Countries. The Final Shelf Life Is Not Less Than 60%. If The Product Does Not Meet The Technical Specification, The Product Will Be Replaced Within 3 Days After Notification. The Presence Of A Document Confirming The Supply By A Potential Supplier Who Has The Status Of A Manufacturer Or An Official Representative Of The Manufacturer., Cassette Ferritin Ferr (Ferritin) For 250 Tests. Purpose: In Vitro Test For Quantitative Immunochemical Determination Of Human Ferritin In Serum And Plasma On Cobas Ntegra Systems. Reagents And Working Solutions: Glycine Buffer: 0.17 Mol/L, Ph 8.3; Rabbit Globulin: 5 Mg/Ml; Stabilizers And Preservatives Latex Particles Coated With Antibodies Against Human Ferritin (Rabbit): 0.17%; Glycine Buffer: 0.17 Mol/L, Ph 7.3; Stabilizer And Preservative. Storage And Transportation Conditions: Store In The Refrigerator. Expiry Date At 2‑8°C See Expiry Date On Cobas C Kit Label. 12 Weeks When Used Onboard The Analyzer At 10-15°C. Transportation Must Be In Thermal Containers With Cooling Elements At A Temperature Of 2-8 °C, Do Not Expose To Freezing Or Exposure To High Temperatures. The Calibration Is Linear On Six Points, The Frequency Of Calibration Is After Changing The Lot. Measurement Range 5-1000 Μg/L (11.2-2247 Pmol/L, 5-1000 Ng/Ml). The Lower Detection Limit Of The Test Is 5 Μg/L (11.2 Pmol/L, 5 Ng/Ml). Test Reproducibility - No More Than 0.7%. Reagents For The Cobas C 501 Analyzer. The Supplier Must Provide A Certificate Of Product Origin. The Scope Of Delivery Is For Eu Countries. The Final Shelf Life Is Not Less Than 60%. If The Product Does Not Meet The Technical Specification, The Product Will Be Replaced Within 3 Days After Notification. The Presence Of A Document Confirming The Supply By A Potential Supplier Who Has The Status Of A Manufacturer Or An Official Representative Of The Manufacturer., Cassette Transferrin Trsf (Transferrin). Appointment In Vitro Test For Quantitative Determination Of Transferrin In Human Urine On Roche/Hitachi Cobas C Analyzers. Reagents - Working Solutions: R1 Phosphate Buffer: 55 Mmol/L, Ph 7.2; Nacl: 25 Mmol/L; Polyethylene Glycol: 5%; Preservative R2 Antibodies Against Human (Rabbit) Transferrin: Depends On The Titer; Nacl: 100 Mmol/L; Preservative Ready For Use. Storage And Stability Of Trsf2. Shelf Life At 2 8 °C: See The Expiry Date On The Label Of The Cobas C Cassette. Shelf Life Of The Opened Reagent In The Refrigerator On Board The Analyzer: 8 Weeks. The Supplier Is Obliged To Provide A Certificate Of Origin Of The Goods. The Scope Of Delivery Is For Eu Countries. The Final Shelf Life Is Not Less Than 60%. If The Product Does Not Meet The Technical Specification, The Product Will Be Replaced Within 3 Days After Notification. The Presence Of A Document Confirming The Supply By A Potential Supplier Who Has The Status Of A Manufacturer Or An Official Representative Of The Manufacturer., Cassette Triglycerides Trigl (Tryglicerides) For 250 Tests. Purpose: The Test For In Vitro Diagnostics Is Intended For The Quantitative Determination Of The Concentration Of Triglycerides In Serum And Blood Plasma Human On Cobas Integra Analyzers Reagents And Working Solutions: Pipes Buffer: 50 Mmol/L, Ph 6.8; Mg2+: 40 Mmol/L; Sodium Cholate: 0.20 Mmol/L; Atp: ≥ 1.4 Mmol/L; 4-Aminophenazone: ≥ 0.13 Mmol/L; 4-Chlorophenol: 4.7 Mmol/L; Lpl (Bacterial): ≥ 83 Μkat/L; Gc (Bacterial): ≥ 3 Μkat/L; Hpo (Bacterial): ≥ 41 Μkat/L; Pod (Horseradish): ≥ 1.6 Μcat/L; Preservative; Stabilizer R Is In Position B. Storage And Transportation Conditions: Store In The Refrigerator. Expiry Date At 2‑8°C See Expiry Date On Cobas C Kit Label. When Used Onboard The Analyzer At 10-15°C 6 Weeks. Transportation Must Be In Thermal Containers With Cooling Elements At A Temperature Of 2-8 °C, Do Not Expose To Freezing Or Exposure To High Temperatures. The Calibration Is Linear At Two Points, The Frequency Of Calibration Is After Changing The Lot. Measurement Range 0.1‑10 Mmol/L (8.85‑885 Mg/Dl). The Lower Detection Limit Of The Test Is 0.1 Mmol/L (8.85 Mg/Dl). Test Reproducibility - No More Than 1.6%. The Supplier Is Obliged To Provide A Certificate Of Origin Of The Goods. The Scope Of Delivery Is For Eu Countries. The Final Shelf Life Is Not Less Than 60%. If The Product Does Not Meet The Technical Specification, The Product Will Be Replaced Within 3 Days After Notification. The Presence Of A Document Confirming The Supply By A Potential Supplier Who Has The Status Of A Manufacturer Or An Official Representative Of The Manufacturer., Cassettes Cobas Integra/Cobas C Systems Creatinine Creaj2 For 700 Tests. Purpose: Kit For In Vitro Diagnostics. Intended For Quantitative Determination Of Creatinine In Human Serum And Plasma On Cobas Integra Analyzers Reagents And Working Solutions: R1 Potassium Hydroxide: 900 Mmol/L; Phosphate: 135 Mmol/L; Ph ≥ 13.5 Sr Picric Acid: 38 Mmol/L; Ph 6.5; Non-Reactive Buffer R1 Is Located In Position B, Sr — In Position C. Storage And Transportation Conditions: Store At Room Temperature. Expiry Date At 15-25°C See Expiry Date On Cobas C Kit Label. When Used Onboard The Analyzer At 10-15°C 8 Weeks. Transportation Must Be In Thermal Containers, Do Not Expose To Freezing Or Exposure To High Temperatures. Calibration Is Linear On Two Points, Calibration Frequency - Each Cassette, Calibration Frequency Is 7 Days. Measurement Range 0.027-32.5 Mmol/L (0.31-367 Mg/Dl). The Lower Detection Limit Of The Test Is 0.027 Mmol/L (0.31 Mg/Dl). Test Reproducibility - No More Than 0.8%. Reagents For The Cobas C 501 Analyzer. The Supplier Must Provide A Certificate Of Product Origin. The Scope Of Delivery Is For Eu Countries. The Final Shelf Life Is Not Less Than 60%. If The Product Does Not Meet The Technical Specification, The Product Will Be Replaced Within 3 Days After Notification. The Presence Of A Document Confirming The Supply By A Potential Supplier Who Has The Status Of A Manufacturer Or An Official Representative Of The Manufacturer., Cassettes Cobas Integra/Cobas C Systems Urea/Urea Nitrogen Ureal For 500 Tests. Purpose: Kit For In Vitro Diagnostics. It Is Intended For The Quantitative Determination Of Urea/Urea Nitrogen In Human Serum, Plasma And Urine. Reagents And Working Solutions: R1 Nacl 9% R2 Tris Buffer: 220 Mmol/L, Ph 8.6; 2-Oxoglutarate: 73 Mmol/L; Nadh: 2.5 Mmol/L; Adp: 6.5 Mmol/L; Urease (Canavalia Macevidnaya): ≥ 300 Μcat/L; Gldh (Bovine Liver): ≥ 80 Μcat/L; Preservative; Non-Reactive Stabilizers R1 Is In Position C, R2 Is In Position B. Storage And Transportation Conditions: Store In A Refrigerator. Expiry Date At 2‑8°C See Expiry Date On Cobas C Kit Label. When Used Onboard The Analyzer At 10-15°C 8 Weeks. Transportation Must Be In Thermal Containers With Cooling Elements At A Temperature Of 2-8 °C, Do Not Expose To Freezing Or Exposure To High Temperatures. The Calibration Is Linear At Two Points, The Frequency Of Calibration Is After Changing The Lot. Measurement Range 6.0-125 Μmol/L (33.5-700 Μg/Dl). The Lower Detection Limit Of The Test Is 6.0 Μmol/L (33.5 Μg/Dl). Test Reproducibility - No More Than 0.8%. Reagents For The Cobas C 501 Analyzer. The Supplier Must Provide A Certificate Of Product Origin. The Scope Of Delivery Is For Eu Countries. The Final Shelf Life Is Not Less Than 60%. If The Product Does Not Meet The Technical Specification, The Product Will Be Replaced Within 3 Days After Notification. The Presence Of A Document Confirming The Supply By A Potential Supplier Who Has The Status Of A Manufacturer Or An Official Representative Of The Manufacturer., Phosphorus Phos (Phosphate) Cassette For 250 Tests. Purpose: Kit For In Vitro Diagnostics. It Is Intended For The Quantitative Determination Of Phosphorus In Human Serum, Plasma And Urine. Reagents And Working Solutions: R1 Sulfuric Acid: 0.36 Mol/L; Detergent R2 Ammonium Molybdate: 3.5 Mmol/L; Sulfuric Acid: 0.36 Mol/L; Sodium Chloride: 150 Mmol/L R1 Is In Position B, R2 Is In Position C. Storage And Transportation Conditions: Store In A Refrigerator. Expiry Date At 2‑8°C See Expiry Date On Cobas C Kit Label. When Used Onboard The Analyzer At 10-15°C 6 Weeks. Transportation Must Be In Thermal Containers With Cooling Elements At A Temperature Of 2-8 °C, Do Not Expose To Freezing Or Exposure To High Temperatures. The Calibration Is Linear At Two Points, The Frequency Of Calibration Is After Changing The Lot. Measurement Range 0.10-6.46 Mmol/L (0.31-20.0 Mg/Dl). The Lower Detection Limit Of The Test Is 0.10 Mmol/L (0.31 Mg/Dl). Test Reproducibility - No More Than 0.6%. Reagents For The Cobas C 501 Analyzer. The Supplier Must Provide A Certificate Of Product Origin. The Scope Of Delivery Is For Eu Countries. The Final Shelf Life Is Not Less Than 60%. If The Product Does Not Meet The Technical Specification, The Product Will Be Replaced Within 3 Days After Notification. The Presence Of A Document Confirming The Supply By A Potential Supplier Who Has The Status Of A Manufacturer Or An Official Representative Of The Manufacturer., Cassette Latent Iron-Binding Capacity Uibc (Unsaturated Iron-Binding Capacity) For 100 Tests. Purpose: In Vitro Test For Quantitative Determination Of The Unsaturated Iron-Binding Capacity Of Blood Serum And Human Plasma. Reagents And Working Solutions: R1 Iron Chloride: 62 Μmol/L; Sodium Bicarbonate: 75 Mmol/L; Tris Buffer: 375 Mmol/L, Ph 8.4; Preservative R3 Ferrosin: 20 Mmol/L; Hydroxylamine: 160 Mmol/L, Ph 2.5 R1 Is In Position A And R3 Is In Position C. Position B Contains H2o For Technical Reasons. Storage And Transportation Conditions: Store In The Refrigerator. Expiry Date At 2‑8°C See Expiry Date On Cobas C Kit Label. When Used Onboard The Analyzer At 10-15°C 8 Weeks. Transportation Must Be In Thermal Containers With Cooling Elements At A Temperature Of 2-8 °C, Do Not Expose To Freezing Or Exposure To High Temperatures. The Calibration Is Linear At Two Points, The Frequency Of Calibration Is After Changing The Lot. Measurement Range 6.0-125 Μmol/L (33.5-700 Μg/Dl). The Lower Detection Limit Of The Test Is 6.0 Μmol/L (33.5 Μg/Dl). Test Reproducibility - No More Than 0.8%. Reagents For The Cobas C 501 Analyzer. The Supplier Must Provide A Certificate Of Product Origin. The Scope Of Delivery Is For Eu Countries. The Final Shelf Life Is Not Less Than 60%. If The Product Does Not Meet The Technical Specification, The Product Will Be Replaced Within 3 Days After Notification. The Presence Of A Document Confirming The Supply By A Potential Supplier Who Has The Status Of A Manufacturer Or An Official Representative Of The Manufacturer., Cassette Glycolized Hemoglobin A1c (Hemoglobin A1c) For 150 Tests. Purpose: In Vitro Test For The Quantitative Determination Of Hemoglobin A1c (Mfkhlm) In Mmol/Mol And % Hemoglobin A1c (Icdpo/Npsg) In Hemolysate Prepared From Whole Blood Using Roche Clinical Chemistry Analyzers. Determination Of Hba1c Concentration Is Useful For Monitoring Long-Term Control Of Levels Blood Glucose In Patients With Diabetes. In Addition, This Test Is Used As An Aid In The Diagnosis Of Diabetes And To Identify Patients Who May Have It Are At Risk Of Developing Diabetes. Reagents And Working Solutions: R1 Reagent With Antibodies Mes Bufferb): 0.025 Mol/L; Tris Bufferc): 0.015 Mol/L, Ph 6.2; Hba1c Antibody (Sheep Serum): ≥ 0.5 Mg/Ml; Detergents, Stabilizers; Preservative Sr Polyhapten Reagent Mes-Buffer: 0.025 Mol/L; Tris Buffer: 0.015 Mol/L, Ph 6.2; Hba1c Polyhapten: ≥ 8 Μg/Ml; Detergents, Stabilizers; Preservative Storage And Transportation Conditions: Store In The Refrigerator. Expiry Date At 2‑8°C See Expiry Date On Cobas C Kit Label. 12 Weeks When Used Onboard The Analyzer At 10-15°C. Transportation Must Be In Thermal Containers With Cooling Elements At A Temperature Of 2-8 °C, Do Not Expose To Freezing Or Exposure To High Temperatures. The Calibration Is Linear On Six Points, The Frequency Of Calibration Is After Changing The Lot. Measurement Range Hemoglobin: 2.48‑24.8 Mmol/L (4‑40 G/Dl), Hba1c: 0.186‑1.61 Mmol/L (0.3‑2.6 G/Dl). The Lower Detection Limit Of The Test Hemoglobin: 2.48-24.8 Mmol/L (4-40 G/Dl), Hba1c: 0.186-1.61 Mmol/L (0.3-2.6 G/Dl). Test Reproducibility - No More Than 1.1%. Reagents For The Cobas C 501 Analyzer., Low-Density Lipoproteins Ldl-C (Ldl-Cholesterol) Cassette For 200 Tests. Purpose: In Vitro Test For Quantitative Determination Of Ldl Cholesterol In Human Serum And Plasma On Cobas Integra Systems. Reagents And Working Solutions: R1 Bis‑Trisb) Buffer: 20.1 Mmol/L, Ph 7.0; 4-Aminoantipyrine: 0.98 Mmol/L; Ascorbate Oxidase (Aod, Acremonium Spec.): ≥ 66.7 Μkat/L; Peroxidase (Recombinant From Basidiomycete): ≥ 166.7 Μkat/L; Bsa: 4.0 G/L; Preservative Sr Mopsc) Buffer: 20.1 Mmol/L, Ph 7.0; Emse: 2.16 Mmol/L; Cholesterol Esterase (Pseudomonads): ≥ 33.3 Μkat/L; Cholesterol Oxidase (Recombinant From E. Coli): ≥ 31.7 Μkat/L; Peroxidase (Recombinant From Basidiomycetes): ≥ 333.3 Μkat/L; Bsa: 4.0 G/L; Detergents; Preservative B) Bis(2‑Hydroxyethyl)‑Amino‑Tris‑(Hydroxymethyl)‑Methane C) 3‑Morpholinopropane‑1‑Sulfonic Acid R1 Is Located In Position B, Sr - In Position C. Storage And Transportation Conditions: Store In A Refrigerator. Expiry Date At 2‑8°C See Expiry Date On Cobas C Kit Label. When Used Onboard The Analyzer At 10-15°C 6 Weeks. Transportation Must Be In Thermal Containers With Cooling Elements At A Temperature Of 2-8 °C, Do Not Expose To Freezing Or Exposure To High Temperatures. The Calibration Is Linear At Two Points, The Frequency Of Calibration Is After Changing The Lot. Measurement Range 0.10-14.2 Mmol/L (3.87-549 Mg/Dl). The Lower Detection Limit Of The Test Is 0.10 Mmol/L (3.87 Mg/Dl). Test Reproducibility - No More Than 2%. Reagents For The Cobas C 501 Analyzer. The Supplier Must Provide A Certificate Of Product Origin. The Scope Of Delivery Is For Eu Countries. The Final Shelf Life Is Not Less Than 60%. If The Product Does Not Meet The Technical Specification, The Product Will Be Replaced Within 3 Days After Notification. The Presence Of A Document Confirming The Supply By A Potential Supplier Who Has The Status Of A Manufacturer Or An Official Representative Of The Manufacturer., Altl Alanine Aminotransferase (Alanine Aminotransferase Acc.To Ifcc) Cassette, 500 Tests. Purpose: An In Vitro Diagnostic Test Intended For The Quantitative Determination Of The Catalytic Activity Of Alt (Ec 2.6.1.2; L‑Alanine: 2‑Oxoglutarate Aminotransferase) In Human Blood Serum And Plasma Using Cobas Integra Systems. Reagents And Working Solutions: R1 Tris Buffer: 224 Mmol/L, Ph 7.3 (37 °C); L‑Alanine: 1120 Mmol/L; Albumin (Bovine): 0.25%; Lactate Hydrogenase (Bacterial): ≥ 45 Μkat/L; Stabilizers; Preservative Sr 2‑Oxoglutarate: 94 Mmol/L; Nadh: ≥ 1.7 Mmol/L; Preservative R1 Is In Position B, Sr Is In Position C. Storage And Transportation Conditions: Store In A Refrigerator. Expiry Date At 2‑8°C See Expiry Date On Cobas C Kit Label. 4 Weeks When Used Onboard The Analyzer At 10-15°C. Transportation Must Be In Thermal Containers With Cooling Elements At A Temperature Of 2-8 °C, Do Not Expose To Freezing Or Exposure To High Temperatures. The Calibration Is Linear At Two Points, The Frequency Of Calibration Is After Changing The Lot. The Lower Detection Limit Of The Test: 2 U/L (0.03 Kcat/L). Test Reproducibility - No More Than 1%. Reagents For The Cobas C 501 Analyzer. The Supplier Must Provide A Certificate Of Product Origin. The Scope Of Delivery Is For Eu Countries. The Final Shelf Life Is Not Less Than 60%. If The Product Does Not Meet The Technical Specification, The Product Will Be Replaced Within 3 Days After Notification. The Presence Of A Document Confirming The Supply By A Potential Supplier Who Has The Status Of A Manufacturer Or An Official Representative Of The Manufacturer., Cassette Bilirubin Direct (Bilirubin-Direct) For 350 Tests. Purpose: In Vitro Test For Quantitative Determination Of Direct Bilirubin In Human Serum And Plasma On Roche/Hitachi Cobas C Systems. Reagents And Working Solutions: R1 Phosphoric Acid: 85 Mmol/L; Hedta: 4.0 Mmol/L; Nacl: 50 Mmol/L; Detergent; Ph 1.9 R2 3,5-Dichlorophenyldiazonium: 1.5 Mmol/L; Ph 1.3 R1 Is In Position B, And R2 Is In Position C. Storage And Transportation Conditions: Store In A Refrigerator. Expiry Date At 2‑8°C See Expiry Date On Cobas C Kit Label. 12 Weeks When Used Onboard The Analyzer At 10-15°C. Transportation Must Be In Thermal Containers With Cooling Elements At A Temperature Of 2-8 °C, Do Not Expose To Freezing Or Exposure To High Temperatures. The Calibration Is Linear At Two Points, The Frequency Of Calibration Is After Changing The Lot. The Lower Detection Limit Of The Test Is 1.2 Μmol/L (0.07 Mg/Dl). Test Reproducibility - No More Than 0.5%. Reagents For The Cobas C 501 Analyzer. The Supplier Must Provide A Certificate Of Product Origin. The Scope Of Delivery Is For Eu Countries. The Final Shelf Life Is Not Less Than 60%. If The Product Does Not Meet The Technical Specification, The Product Will Be Replaced Within 3 Days After Notification. The Presence Of A Document Confirming The Supply By A Potential Supplier Who Has The Status Of A Manufacturer Or An Official Representative Of The Manufacturer., Cassette Aspartate Aminotransferase Astl (Aspartate Aminotransferase Acc.To Ifcc) For 500 Tests. Purpose: In Vitro Test For Quantitative Determination Of The Catalytic Activity Of Ast (Ec 2.6.1.1; L-Aspartate: 2-Oxoglutarate Aminotransferase) In Human Blood Serum And Plasma Using Cobas Integra Systems. Reagents And Working Solutions: R1 Tris Buffer: 264 Mmol/L, Ph 7.8 (37°C); L-Aspartate: 792 Mmol/L; Mdg (Bacterial): ≥ 24 Μkat/L; Ldh (Bacterial): ≥ 48 Μkat/L; Albumin (Bovine): 0.25%; Preservative Sr Nadh: ≥ 1.7 Mmol/L; 2-Oxoglutarate: 94 Mmol/L; Preservative R1 Is In Position A, Sr — In Positions B And C. Storage And Transportation Conditions: Store In A Refrigerator. Expiry Date At 2‑8°C See Expiry Date On Cobas C Kit Label. 4 Weeks When Used Onboard The Analyzer At 10-15°C. Transportation Must Be In Thermal Containers With Cooling Elements At A Temperature Of 2-8 °C, Do Not Expose To Freezing Or Exposure To High Temperatures. The Calibration Is Linear At Two Points, The Frequency Of Calibration Is After Changing The Lot. The Lower Detection Limit Of The Test Is 2 U/L (0.03 Μcat/L). Test Reproducibility - No More Than 1.8%. The Supplier Is Obliged To Provide A Certificate Of Origin Of The Goods. The Scope Of Delivery Is For Eu Countries. The Final Shelf Life Is Not Less Than 60%. If The Product Does Not Meet The Technical Specification, The Product Will Be Replaced Within 3 Days After Notification. The Presence Of A Document Confirming The Supply By A Potential Supplier Who Has The Status Of A Manufacturer Or An Official Representative Of The Manufacturer., Lactate Dehydrogenase Ldhi (Lactate Dehydrogenase Ifcc) Cassette For 300 Tests. Purpose: In Vitro Test For Quantitative Determination Of Lactate Dehydrogenase In Serum And Human Blood Plasma On Roche/Hitachi Cobas C Analyzers. Reagents And Working Solutions: R1 N-Methylglucamine: 400 Mmol/L, Ph 9.4 (37°C); Cast Lactate: 62 Mmol/L; Stabilizers R2 Over: 62 Mmol/L; Stabilizers; Preservatives R1 Is Located In Position B And R2 - In Position C. Storage And Transportation Conditions: Store In A Refrigerator. Expiry Date At 2‑8°C See Expiry Date On Cobas C Kit Label. 12 Weeks When Used Onboard The Analyzer At 10-15°C. Transportation Must Be In Thermal Containers With Cooling Elements At A Temperature Of 2-8 °C, Do Not Expose To Freezing Or Exposure To High Temperatures. The Calibration Is Linear At Two Points, The Frequency Of Calibration Is After Changing The Lot. The Lower Detection Limit Of The Test Is 10 U/L (0.167 Μcat/L). Test Reproducibility - No More Than 0.9%. Reagents For The Cobas C 501 Analyzer. The Supplier Must Provide A Certificate Of Product Origin. The Scope Of Delivery Is For Eu Countries. The Final Shelf Life Is Not Less Than 60%. If The Product Does Not Meet The Technical Specification, The Product Will Be Replaced Within 3 Days After Notification. The Presence Of A Document Confirming The Supply By A Potential Supplier Who Has The Status Of A Manufacturer Or An Official Representative Of The Manufacturer., Cassette Albumin Bromcresol Green Alb (Albumin Bromcresol Green) For 300+C13+D16, Alkaline Phosphatase Alp (Alkaline Phosphatase Ifcc) Cassette For 400 Tests. Purpose: In Vitro Test For Quantitative Determination Of The Catalytic Activity Of Alkaline Phosphatase (Ec 3.1.3.1; Orthophosphoric Monoester Phosphohydrolase) In Human Blood Serum And Plasma. Reagents And Working Solutions: R1 2-Amino-2-Methyl-1-Propanol: 1.724 Mol/L, Ph 10.44 (30°C); Magnesium Acetate: 3.83 Mmol/L; Zinc Sulfate: 0.766 Mmol/L; N-(2-Hydroxyethyl)-Ethylenediamine Acetylacetoacetic Acid: 3.83 Mmol/L Sr P-Nitrophenyl Phosphate: 132.8 Mmol/L, Ph 8.5 (25°C); R1 Preservatives Are In Position B, Sr — In Position C. Storage And Transportation Conditions: Store In A Refrigerator. Expiry Date At 2‑8°C See Expiry Date On Cobas C Kit Label. 4 Weeks When Used Onboard The Analyzer At 10-15°C. Transportation Must Be In Thermal Containers With Cooling Elements At A Temperature Of 2-8 °C, Do Not Expose To Freezing Or Exposure To High Temperatures. The Calibration Is Linear At Two Points, The Frequency Of Calibration Is After Changing The Lot. The Lower Detection Limit Of The Test Is 5 U/L (0.084 Μcat/L). Test Reproducibility - No More Than 0.7%. Reagents For The Cobas C 501 Analyzer. The Supplier Must Provide A Certificate Of Product Origin. The Scope Of Delivery Is For Eu Countries. The Final Shelf Life Is Not Less Than 60%. If The Product Does Not Meet The Technical Specification, The Product Will Be Replaced Within 3 Days After Notification. The Presence Of A Document Confirming The Supply By A Potential Supplier Who Has The Status Of A Manufacturer Or An Official Representative Of The Manufacturer., Cassette Bilirubin Total Bilt (Bilirubin-Total Dpd) For 250 Tests. Purpose: In Vitro Test For The Quantitative Determination Of The Total Content Of Bilirubin In The Serum And Plasma Of Human Blood (Adults And Newborns) On Roche/Hitachi Cobas C Analyzers. Reagents And Working Solutions: R1 Phosphate: 50 Mmol/L; Detergents; Stabilizers; Ph 1.0 R2 3,5‑Dichlorophenyl Diazonium Salt: ≥ 1.35 Mmol/L R1 Is In Position B And R2 Is In Position C. Storage And Transportation Conditions: Store In A Refrigerator. Expiry Date At 2‑8°C See Expiry Date On Cobas C Kit Label. 12 Weeks When Used Onboard The Analyzer At 10-15°C. Transportation Must Be In Thermal Containers With Cooling Elements At A Temperature Of 2-8 °C, Do Not Expose To Freezing Or Exposure To High Temperatures. The Calibration Is Linear At Two Points, The Frequency Of Calibration Is After Changing The Lot. The Lower Detection Limit Of The Test Is 1.7 Μmol/L (0.999 Mg/Dl). Test Reproducibility - No More Than 0.6%. Reagents For The Cobas C 501 Analyzer. The Supplier Must Provide A Certificate Of Product Origin. The Scope Of Delivery Is For Eu Countries. The Final Shelf Life Is Not Less Than 60%. If The Product Does Not Meet The Technical Specification, The Product Will Be Replaced Within 3 Days After Notification. The Presence Of A Document Confirming The Supply By A Potential Supplier Who Has The Status Of A Manufacturer Or An Official Representative Of The Manufacturer., Cassette Calcium Ca (Calcium) For 400 Tests. Purpose: Test For In Vitro Diagnostics, Intended For Quantitative Determination Of Calcium In Human Serum, Plasma And Urine On Cobas Integra Analyzers. Reagents And Working Solutions: R1 Capso: A) 557 Mmol/L; Nm‑Bapta: 2 Mmol/L, Ph 10.0; Non-Reactive Surfactant; Preservative Sr Edta: 7.5 Mmol/L; Ph 7.3; Non-Reactive Surfactant; Preservative Storage And Transportation Conditions: Store In The Refrigerator. Expiry Date At 2‑8°C See Expiry Date On Cobas C Kit Label. 12 Weeks When Used Onboard The Analyzer At 10-15°C. Transportation Must Be In Thermal Containers With Cooling Elements At A Temperature Of 2-8 °C, Do Not Expose To Freezing Or Exposure To High Temperatures. The Calibration Is Linear At Two Points, The Frequency Of Calibration Is After Changing The Lot. Measurement Range 0.20-5.0 Mmol/L (0.8-20.1 Mg/Dl). The Lower Detection Limit Of The Test Is 0.10 Mmol/L (0.4 Mg/Dl). Test Reproducibility - No More Than 0.8%. Reagents For The Cobas C 501 Analyzer. The Supplier Must Provide A Certificate Of Product Origin. The Scope Of Delivery Is For Eu Countries. The Final Shelf Life Is Not Less Than 60%. If The Product Does Not Meet The Technical Specification, The Product Will Be Replaced Within 3 Days After Notification. The Presence Of A Document Confirming The Supply By A Potential Supplier Who Has The Status Of A Manufacturer Or An Official Representative Of The Manufacturer., Amylase Cassette Amyl (Amylase) For Analyzers For 300 Tests. Purpose: Kit For In Vitro Diagnostics, Intended For Quantitative Determination Of The Catalytic Activity Of Α-Amylase (Ec 3.2.1.1; 1,4-Α-D-Glucan: Glucanohydrolase) In Human Serum, Plasma And Urine. Reagents And Working Solutions: R1 Hepes: 52.4 Mmol/L; Sodium Chloride: 87 Mmol/L; Calcium Chloride: 0.08 Mmol/L; Magnesium Chloride: 12.6 Mmol/L; Α‑Glucosidase (Bacterial): ≥ 66.8 Μkat/L; Ph 7.0 (37 °C); Preservative; Sr Hepes Stabilizers: 52.4 Mmol/L; Ethylidene-G7-Pnp: 22 Mmol/L; Ph 7.0 (37 °C); Detergent; Stabilizers R1 Are In Position B, Sr — In Position C. Storage And Transportation Conditions: Store In A Refrigerator. Expiry Date At 2‑8°C See Expiry Date On Cobas C Kit Label. 4 Weeks When Used Onboard The Analyzer At 10-15°C. Transportation Must Be In Thermal Containers With Cooling Elements At A Temperature Of 2-8 °C, Do Not Expose To Freezing Or Exposure To High Temperatures. The Calibration Is Linear At Two Points, The Frequency Of Calibration Is After Changing The Lot. The Lower Detection Limit Of The Test Is 3 U/L (0.05 Μcat/L). Test Reproducibility - No More Than 1.2%. Reagents For The Cobas C 501 Analyzer. The Supplier Must Provide A Certificate Of Product Origin. The Scope Of Delivery Is For Eu Countries. The Final Shelf Life Is Not Less Than 60%. If The Product Does Not Meet The Technical Specification, The Product Will Be Replaced Within 3 Days After Notification., Cassette Cholesterin Chol (Cholesterol) For 400 Tests. Purpose: In Vitro Diagnostic Test For Quantitative Determination Of Total Cholesterol In Human Serum And Plasma On Cobas Analyzers. Reagents And Working Solutions: R Pipesa): 225 Mmol/L, Ph 6.8; Mg2+: 10 Mmol/L; Sodium Cholate: 0.6 Mmol/L; 4-Aminoantipyrine: ≥ 0.45 Mmol/L; Phenol ≥ 12.6 Mmol/L; Polyglycol Ether Of Fatty Alcohols: 3%; Cholesterol Esterase (Pseudomonas Spec.): ≥ 25 Μkat/L (≥ 1.5 U/Ml); Cholesterol Oxidase (E. Coli): ≥ 7.5 Μcat/L (≥ 0.45 U/Ml); Peroxidase (Horseradish): ≥ 12.5 Μcat/L (≥ 0.75 U/Ml); Stabilizers; Preservative A) Pipes = Buffer Solution Of Piperazine-1,4-Bis(2-Ethanesulfonic Acid R Is In Position B. Storage And Transportation Conditions: Store In A Refrigerator. Shelf Life At 2‑8 °C. See Shelf Life On The Label Of The Cobas Kit C. When Using The Analyzer At 10-15 °C, It Must Be Transported In Thermal Containers At A Temperature Of 2-8 °C The Measurement Range Is 0.1-20.7 Mmol/L. The Lower Limit Of Detection Is 0.1 Mmol/L. The Supplier Is Obliged To Provide A Certificate Of Origin. The Delivery Period Is Not Less Than 60%. If The Product Does Not Meet The Technical Specification, It Will Be Replaced Within 3 Days., Cassette Gamma-Glutamyltransferase Ggt (Gamma-Glutamyltransferase) For Cobas Analyzers For 400 Tests. Purpose: In Vitro Diagnostic Test Intended For Quantitative Determination Of The Catalytic Activity Of Ggtp (Ec 2.3.2.2; Γ-Glutamyl Peptide: Amino Acid Γ-Glutamyltransferase) In Human Serum And Plasma On Cobas Analyzers. Reagents And Working Solutions: R1 Tris: 492 Mmol/L, Ph 8.25; Glycylglycine: 492 Mmol/L; Preservative; Additives Sr L-Γ-Glutamyl-3-Carboxy-4-Nitroanilide: 22.5 Mmol/L; Acetate: 10 Mmol/L, Ph 4.5; Stabilizers, Preservatives R1 Is In Position B, Sr — In Position C. Storage And Transportation Conditions: Store In A Refrigerator. Expiry Date At 2‑8°C See Expiry Date On Cobas C Kit Label. 12 Weeks When Used Onboard The Analyzer At 10-15°C. Transportation Must Be In Thermal Containers With Cooling Elements At A Temperature Of 2-8 °C, Do Not Expose To Freezing Or Exposure To High Temperatures. The Calibration Is Linear At Two Points, The Frequency Of Calibration Is After Changing The Lot. The Lower Detection Limit Of The Test Is 3 U/L (0.05 Μcat/L). Test Reproducibility - No More Than 0.7%. Reagents For The Cobas C 501 Analyzer. The Supplier Must Provide A Certificate Of Product Origin. The Scope Of Delivery Is For Eu Countries. The Final Shelf Life Is Not Less Than 60%. If The Product Does Not Meet The Technical Specification, The Product Will Be Replaced Within 3 Days After Notification. The Presence Of A Document Confirming The Supply By A Potential Supplier Who Has The Status Of A Manufacturer Or An Official Representative Of The Manufacturer., Cassette Antistreptolysin Aslo (Antistreptolysin O) For 150 Tests. Purpose: Set For In Vitro Diagnostics. Intended For Quantitative Determination Of Antibodies To Streptolysin O In Serum And Plasma Of Human Blood On Roche/Hitachi Cobas C Analyzers. Reagents And Working Solutions: R1 Tris Buffer: 170 Mmol/L, Ph 8.2 R2 Borate Buffer: 10 Mmol/L, Ph 8.2; Latex Particles Coated With Streptolysin O: 2 Ml/L R1 Is In Position B, R2 Is In Position C. Storage And Transportation Conditions: Store In A Refrigerator. Expiry Date At 2‑8°C See Expiry Date On Cobas C Kit Label. 12 Weeks When Used Onboard The Analyzer At 10-15°C. Transportation Must Be In Thermal Containers With Cooling Elements At A Temperature Of 2-8 °C, Do Not Expose To Freezing Or Exposure To High Temperatures. The Calibration Is Linear At Two Points, The Frequency Of Calibration Is After Changing The Lot. Measuring Range 20-600 Iu/Ml. The Lower Detection Limit Of The Test Is 20 Iu/Ml. Test Reproducibility - No More Than 1.1%. Reagents For The Cobas C 501 Analyzer. The Supplier Must Provide A Certificate Of Product Origin. The Scope Of Delivery Is For Eu Countries. The Final Shelf Life Is Not Less Than 60%. If The Product Does Not Meet The Technical Specification, The Product Will Be Replaced Within 3 Days After Notification. The Presence Of A Document Confirming The Supply By A Potential Supplier Who Has The Status Of A Manufacturer Or An Official Representative Of The Manufacturer., Cassette Rheumatoid Factor Ii Rf-Ii (Rheumatoid Factors Ii) For 100 Tests. Purpose: Kit For In Vitro Diagnostics. Intended For Quantitative Determination Of Rheumatoid Factor (Rf-Ii) In Human Serum And Plasma On Roche/Hitachi Cobas C Analyzers. Measurements Can Be Used As An Aid In The Diagnosis Of Rheumatoid Arthritis. Reagents And Working Solutions: R1 Glycine Buffer: 170 Mmol/L, Ph 8.0; Polyethylene Glycol: 0.05%; Bovine Serum Albumin; Stabilizer; Preservative R2 Latex Particles Coated With Human Igg; Glycine Buffer Solution: 170 Mmol/L, Ph 7.3; Stabilizers, Preservatives R1 Is In Position B, R2 Is In Position C. Storage And Transportation Conditions: Store In A Refrigerator. Expiry Date At 2‑8°C See Expiry Date On Cobas C Kit Label. 12 Weeks When Used Onboard The Analyzer At 10-15°C. Transportation Must Be In Thermal Containers With Cooling Elements At A Temperature Of 2-8 °C, Do Not Expose To Freezing Or Exposure To High Temperatures. The Calibration Is Linear On Six Points, The Frequency Of Calibration Is After Changing The Lot. The Measurement Range Is 10-130 Iu/Ml. The Lower Detection Limit Of The Test Is 10 Iu/Ml. Test Reproducibility - No More Than 1.1%. Reagents For The Cobas C 501 Analyzer. The Supplier Must Provide A Certificate Of Product Origin. The Scope Of Delivery Is For Eu Countries. The Final Shelf Life Is Not Less Than 60%. If The Product Does Not Meet The Technical Specification, The Product Will Be Replaced Within 3 Days After Notification. The Presence Of A Document Confirming The Supply By A Potential Supplier Who Has The Status Of A Manufacturer Or An Official Representative Of The Manufacturer., Cassettes Cobas Integra/Cobas C Systems C-Reactive Protein Crp Lx Latex For 250 Tests. Purpose: Kit For In Vitro Diagnostics. Intended For Quantitative Determination Of C-Reactive Protein In Human Serum And Plasma On Roche/Hitachi Cobas C Analyzers. Reagents And Working Solutions: R1 Tris-Buffer With Bovine Serum Albumin And Immunoglobulins (Mouse); Preservative R2 Latex Particles Coated With Anti-Crp (Mouse) In Glycine Buffer; Preservative R1 Is In Position B, R2 Is In Position C. Storage And Transportation Conditions: Store In A Refrigerator. Expiry Date At 2‑8°C See Expiry Date On Cobas C Kit Label. 12 Weeks When Used Onboard The Analyzer At 10-15°C. Transportation Must Be In Thermal Containers With Cooling Elements At A Temperature Of 2-8 °C, Do Not Expose To Freezing Or Exposure To High Temperatures. The Calibration Is Linear On Six Points, The Frequency Of Calibration Is After Changing The Lot. Measurement Range 1.00-250 Mg/L (9.52-2380 Nmol/L, 0.1-25 Mg/Dl). The Lower Detection Limit Of The Test Is 1.00 Mg/L (9.52 Nmol/L, 0.1 Mg/Dl). Test Reproducibility - No More Than 1.5%. Reagents For The Cobas C 501 Analyzer. The Supplier Must Provide A Certificate Of Product Origin. The Scope Of Delivery Is For Eu Countries. The Final Shelf Life Is Not Less Than 60%. If The Product Does Not Meet The Technical Specification, The Product Will Be Replaced Within 3 Days After Notification. The Presence Of A Document Confirming The Supply By A Potential Supplier Who Has The Status Of A Manufacturer Or An Official Representative Of The Manufacturer., Glucose Cassette (Gluc Hk2) For 800 Tests. Purpose: In Vitro Test For The Quantitative Determination Of Glucose In Cerebrospinal Fluid, Urine, Serum And Plasma Of Human Blood On Roche/Hitachi Cobas C Analyzers. Reagents And Working Solutions: R1 Tris Buffer: 100 Mmol/L, Ph 7.8; Mg2+: 4 Mmol/L; Atp: ≥ 1.7 Mmol/L; Nadp: ≥ 1.0 Mmol/L; Preservative R2 Hepes-Buffer: 30 Mmol/L, Ph 7.0; Mg2+: 4 Mmol/L; Gc (Yeast): ≥ 130 Μcat/L; G-6-Pdh (E. Coli): ≥ 250 Μcat/L; Preservative R1 Is Located In Position B, R2 — In Position C. Storage And Transportation Conditions: Store In A Refrigerator. Expiry Date At 2‑8°C See Expiry Date On Cobas C Kit Label. When Used Onboard The Analyzer At 10-15°C 8 Weeks. Transportation Must Be In Thermal Containers With Cooling Elements At A Temperature Of 2-8 °C, Do Not Expose To Freezing Or Exposure To High Temperatures. The Calibration Is Linear At Two Points, The Frequency Of Calibration Is After Changing The Lot. Measuring Range 0.11-40 Mmol/L (2-720 Mg/Dl). The Lower Detection Limit Of The Test Is 0.11 Mmol/L (2 Mg/Dl). Test Reproducibility - No More Than 1.6%. Reagents For The Cobas C 501 Analyzer. The Supplier Must Provide A Certificate Of Product Origin. The Scope Of Delivery Is For Eu Countries. The Final Shelf Life Is Not Less Than 60%. If The Product Does Not Meet The Technical Specification, The Product Will Be Replaced Within 3 Days After Notification. The Presence Of A Document Confirming The Supply By A Potential Supplier Who Has The Status Of A Manufacturer Or An Official Representative Of The Manufacturer., High-Density Lipoprotein Hdlc (Hdl-Cholesterol) Cassette For 350 Tests. Purpose: In Vitro Test For The Quantitative Determination Of Hdl-Cholesterol In Human Serum And Plasma On Roche/Hitachi Cobas C Analyzers. Reagents And Working Solutions: R1 Tapsob) Buffer: 62.1 Mmol/L, Ph 7.77; Polyanion: 1.25 G/L; Emse: 1.08 Mmol/L; Ascorbate Oxidase (Pumpkin): ≥ 50 Μkat/L; Peroxidase (Horseradish): ≥ 166.7 Μkat/L; Detergent; Bsa: 2.0 G/L; Preservative R2 Bis-Trisc) Buffer: 20.1 Mmol/L, Ph 6.70; Cholesterol Esterase (Microorganism): ≥ 7.5 Μcat/L; Cholesterol Oxidase (Recombinant E. Coli): ≥ 7.17 Μkat/L; Cholesterol Oxidase (Microorganism): ≥ 76.7 Μcat/L; Peroxidase (Horseradish): ≥ 333 Μcat/L; 4-Amino-Antipyrine: 1.48 Mmol/L; Bsa: 3.0 G/L; Detergents; Preservative. Storage And Transportation Conditions: Store In The Refrigerator. Expiry Date At 2‑8°C See Expiry Date On Cobas C Kit Label. 12 Weeks When Used Onboard The Analyzer At 10-15°C. Transportation Must Be In Thermal Containers With Cooling Elements At A Temperature Of 2-8 °C, Do Not Expose To Freezing Or Exposure To High Temperatures. The Calibration Is Linear At Two Points, The Frequency Of Calibration Is After Changing The Lot. Measurement Range 0.08-3.88 Mmol/L (3.09-150 Mg/Dl). The Lower Detection Limit Of The Test Is 0.08 Mmol/L (3.09 Mg/Dl). Test Reproducibility - No More Than 1.1%. Reagents For The Cobas C 501 Analyzer. The Supplier Must Provide A Certificate Of Product Origin. The Scope Of Delivery Is For Eu Countries. The Final Shelf Life Is Not Less Than 60%. If The Product Does Not Meet The Technical Specification, The Product Will Be Replaced Within 3 Days After Notification. The Presence Of A Document Confirming The Supply By A Potential Supplier Who Has The Status Of A Manufacturer Or An Official Representative Of The Manufacturer., Cassettes Cobas Integra/Cobas C Systems Total Protein Tr2 For 300 Tests. Purpose: Test For In Vitro Diagnostics, Intended For Quantitative Determination Of Total Protein Concentration In Human Serum And Plasma. Reagents And Working Solutions: R1 Sodium Hydroxide: 400 Mmol/L; Potassium Sodium Tartrate: 89 Mmol/L; Ph: 13.4 Sr Sodium Hydroxide: 400 Mmol/L; Potassium Sodium Tartrate: 89 Mmol/L; Potassium Iodide: 61 Mmol/L; Copper Sulfate: 24.3 Mmol/L; Ph: 13.2 R1 Is In Position B, Sr Is In Position C. Storage And Transportation Conditions: Store At Room Temperature. Expiry Date At 15-25°C See Expiry Date On Cobas C Kit Label. 4 Weeks When Used Onboard The Analyzer At 10-15°C. Transportation Must Be In Thermal Containers, Do Not Expose To Freezing Or Exposure To High Temperatures. The Calibration Is Linear At Two Points, The Frequency Of Calibration Is After Changing The Lot. Measuring Range 2‑120 G/L (0.2‑12 G/Dl). The Lower Detection Limit Of The Test Is 2 G/L (0.2 G/Dl). Test Reproducibility - No More Than 0.6%. Reagents For The Cobas C 501 Analyzer. The Supplier Must Provide A Certificate Of Product Origin. The Scope Of Delivery Is For Eu Countries. The Final Shelf Life Is Not Less Than 60%. If The Product Does Not Meet The Technical Specification, The Product Will Be Replaced Within 3 Days After Notification. The Presence Of A Document Confirming The Supply By A Potential Supplier Who Has The Status Of A Manufacturer Or An Official Representative Of The Manufacturer., Cassette Magnesium Mg (Magnesium) For 250 Tests. Purpose: Set For In Vitro Diagnostics. Intended For Quantitative Determination Of Magnesium In Human Serum, Plasma And Urine On Roche/Hitachi Cobas C Analyzers. Reagents And Working Solutions: R1 Trisa /6-Buffer Solution Of Aminocaproic Acids: 500 Mmol/L, Ph 11.25; Egtc: 129 Μmol/L; Preservative R2 Xylidyl Blue: 0.28 Mmol/L; Detergent; Preservative A) Tris = Tris(Hydroxymethyl)-Aminomethane R1 Is In Position B, R2 Is In Position C. Storage And Transportation Conditions: Store In A Refrigerator. Expiry Date At 2‑8°C See Expiry Date On Cobas C Kit Label. When Used Onboard The Analyzer At 10-15°C 6 Weeks. Transportation Must Be In Thermal Containers With Cooling Elements At A Temperature Of 2-8 °C, Do Not Expose To Freezing Or Exposure To High Temperatures. The Calibration Is Linear At Two Points, The Frequency Of Calibration Is After Changing The Lot. Measurement Range 0.10-2.0 Mmol/L (0.243-4.86 Mg/Dl). The Lower Detection Limit Of The Test Is 0.10 Mmol/L (0.243 Mg/Dl). Test Reproducibility - No More Than 0.8%. Reagents For The Cobas C 501 Analyzer. The Supplier Must Provide A Certificate Of Product Origin. The Scope Of Delivery Is For Eu Countries. The Final Shelf Life Is Not Less Than 60%. If The Product Does Not Meet The Technical Specification, The Product Will Be Replaced Within 3 Days After Notification. The Presence Of A Document Confirming The Supply By A Potential Supplier Who Has The Status Of A Manufacturer Or An Official Representative Of The Manufacturer., Cassette Uric Acid Ua (Uric Acid) For 400 Tests. Purpose: Kit For In Vitro Diagnostics. It Is Intended For Quantitative Determination Of Uric Acid Concentration In Serum, Plasma And Urine. Reagents And Working Solutions: R1 Phosphate Buffer: 0.05 Mol/L, Ph 7.8; Toos: 7 Mmol/L; Polyglycol Ester Of Fatty Alcohol: 4.8%; Ascorbate Oxidase (Ec 1.10.3.3; Zucchini) ≥ 83.5 Μcat/L (25°C); Stabilizers; Preservative Sr Phosphate Buffer: 0.1 Mol/L, Ph 7.8; Potassium Hexacyanoferrate (Ii): 0.3 Mmol/L; 4-Aminophenazone ≥ 3 Mmol/L; Uricase (Ec 1.7.3.3; Arthrobacter Protophormiae) ≥ 83.4 Μcat/L (25°C); Peroxidase (Pod) (Ec 1.11.1.7; Horseradish) ≥ 50 Μcat/L (25°C); Stabilizers; Preservative R1 Is Located In Position B, Sr - In Position C. Storage And Transportation Conditions: Store In A Refrigerator. Expiry Date At 2‑8°C See Expiry Date On Cobas C Kit Label. When Used Onboard The Analyzer At 10-15°C 6 Weeks. Transportation Must Be In Thermal Containers With Cooling Elements At A Temperature Of 2-8 °C, Do Not Expose To Freezing Or Exposure To High Temperatures. The Calibration Is Linear At Two Points, The Frequency Of Calibration Is After Changing The Lot. The Measurement Range Is 11.9-1500 Μmol/L (0.20-25 Mg/Dl). The Lower Detection Limit Of The Test Is 11.9 Μmol/L (0.20 Mg/Dl). Test Reproducibility - No More Than 1.8%. Reagents For The Cobas C 501 Analyzer. The Supplier Must Provide A Certificate Of Product Origin. The Scope Of Delivery Is For Eu Countries. The Final Shelf Life Is Not Less Than 60%. If The Product Does Not Meet The Technical Specification, The Product Will Be Replaced Within 3 Days After Notification. The Presence Of A Document Confirming The Supply By A Potential Supplier Who Has The Status Of A Manufacturer Or An Official Representative Of The Manufacturer.