Request For Quotation Laboratory Reagents For Prenatal Screening

The Calibrator For Plasma Pregnancy-Related Protein A Should Be Used To Correct The Standard Curve Stored In B·R·A·H·M·S Kryptor Compact Plus. The Calibrator Must Be Compatible With The Automatic Biochemical Analyzer B•R•A•M•S Kryptor Compact Plus Installed In The Customers Laboratory. The Package Should Consist Of: Papp-A/Prombp Complex Of Human Origin, Human Blood Serum And Sodium Azide; The Label With The Barcode Must Contain Information About The Batch Of The Calibrator, Including The Concentration Value. The Number Of Bottles In The Package Should Be 6; The Stability Of The Calibration Must Be At Least 15 Days; The Principle Of Analysis Should Be A Sandwich Method; The Storage Temperature Should Be No Less Than 2°C And No More Than 8°C. The Product Release Date Must Be No Earlier Than 2024; The Supplier Provides Documents Confirming The Compliance Of The Supplied Goods With The Requirements Established By Technical Regulations, Provisions Of Standards Or Other Documents In Accordance With The Legislation Of The Republic Of Kazakhstan, Including A Registration Certificate With The Ministry Of Health Of The Republic Of Kazakhstan, An Iso 13485 Certificate., The Reconstitution Solution Must Be Used To Reconstitute Freeze-Dried Reagents On The B·R·A·H·M·S Kryptor Compact Plus Analyzer. The Solution Must Be Compatible With The Automatic Biochemical Analyzer B•R•A•M•S Kryptor Compact Plus Installed In The Customers Laboratory; There Should Be At Least 4 Ready-To-Use Bottles Of 55 Ml Each In The Package; The Solution Must Contain A Preservative Of At Least < 0.1%; The Solution Should Remain Stable For At Least 29 Days; The Storage Temperature Should Be No Less Than 2°C And No More Than 8°C. The Product Release Date Must Be No Earlier Than 2024; The Supplier Provides Documents Confirming The Compliance Of The Supplied Goods With The Requirements Established By Technical Regulations, Provisions Of Standards Or Other Documents In Accordance With The Legislation Of The Republic Of Kazakhstan, Including A Registration Certificate With The Ministry Of Health Of The Republic Of Kazakhstan, An Iso 13485 Certificate., The Calibrator For The Free Beta Subunit Of Human Chorionic Gonadotropin Should Be Used To Correct The Standard Curve Stored In B·R·A·H·M·S Kryptor Compact Plus. The Calibrator Must Be Compatible With The Automatic Biochemical Analyzer B•R•A•M•S Kryptor Compact Plus Installed In The Customers Laboratory. The Package Should Consist Of: Ready-To-Use Highly Purified Free Β-Hcg, Serum Of Newborn Calves And Preservatives; The Label With The Barcode Must Contain Information About The Batch Of The Calibrator, Including The Concentration Value. The Number Of Bottles In The Package Should Be 6; The Stability Of The Calibration Must Be At Least 15 Days; The Principle Of Analysis Should Be A Sandwich Method; The Storage Temperature Should Be No Less Than 2°C And No More Than 8°C. The Product Release Date Must Be No Earlier Than 2024; The Supplier Provides Documents Confirming The Compliance Of The Supplied Goods With The Requirements Established By Technical Regulations, Provisions Of Standards Or Other Documents In Accordance With The Legislation Of The Republic Of Kazakhstan, Including A Registration Certificate With The Ministry Of Health Of The Republic Of Kazakhstan, An Iso 13485 Certificate., A Set Of Reagents For Determining The Free Beta Subunit Of Human Chorionic Gonadotropin Should Quantitatively Determine The Concentration Of Free Β-Hcg (Free Beta Subunit Of Human Chorionic Gonadotropin) In Human Blood Serum. The Set Must Be Compatible With The Automatic Biochemical Analyzer B•R•A•M•S Kryptor Compact Plus Installed In The Customers Laboratory. The Set Should Consist Of: Ready-To-Use Xl-Conjugate Containing Monoclonal Antibody To Free Β-Hcg Conjugated With Xl-665, Buffer, Bovine Albumin, Non-Specific Mouse Immunoglobulins, Potassium Fluoride; Ready-To-Use K-Conjugate Containing A Monoclonal Antibody To Free Β-Hcg Conjugated With Europium Cryptate, Buffer, Bovine Albumin, Mouse Non-Specific Immunoglobulins, Potassium Fluoride; Ready-To-Use Diluent Containing Newborn Calf Serum, Preservatives: The Kit Must Have A Sticker With A Bar Code Containing All The Information Necessary To Register A New Batch Of Reagents; The Number Of Tests In The Set Should Be 75; Sample Type - Serum; The Volume Of The Sample Required For The Analysis Should Be At Least 26 Μl; Incubation Time Should Be No More Than 19 Minutes; The Results Must Be Presented In Ng/Ml; The Stability Of The Set In The Analyzer (Stability After Opening) Must Be No Less Than 29 Days; The Principle Of Analysis Should Be A Sandwich Method; The Storage Temperature Should Be No Less Than 2°C And No More Than 8°C. The Product Release Date Must Be No Earlier Than 2024; The Supplier Provides Documents Confirming The Compliance Of The Supplied Goods With The Requirements Established By Technical Regulations, Provisions Of Standards Or Other Documents In Accordance With The Legislation Of The Republic Of Kazakhstan, Including A Registration Certificate With The Ministry Of Health Of The Republic Of Kazakhstan, An Iso 13485 Certificate., The Solution Should Be Intended For Flushing The B·R·A·H·M·S Kryptor Compact/Kryptor Compact Plus Liquid System. The Solution Must Be Compatible With The Automatic Biochemical Analyzer B•R•A•M•S Kryptor Compact Plus Installed In The Customers Laboratory; There Should Be At Least 4 Ready-To-Use Bottles Of 30 Ml Each In The Package; The Solution Should Contain Sodium Hydroxide Not Less Than <0.5% And Sodium Hypochlorite Not Less Than <5.0%.; The Solution Should Remain Stable For At Least 29 Days; The Storage Temperature Should Be No Less Than 2°C And No More Than 8°C. The Product Release Date Must Be No Earlier Than 2024; The Supplier Provides Documents Confirming The Compliance Of The Supplied Goods With The Requirements Established By Technical Regulations, Provisions Of Standards Or Other Documents In Accordance With The Legislation Of The Republic Of Kazakhstan, Including A Registration Certificate With The Ministry Of Health Of The Republic Of Kazakhstan, An Iso 13485 Certificate., The Reconstitution Solution Must Be Used To Reconstitute Freeze-Dried Reagents On The B·R·A·H·M·S Kryptor Compact Plus Analyzer. The Solution Must Be Compatible With The Automatic Biochemical Analyzer B•R•A•M•S Kryptor Compact Plus Installed In The Customers Laboratory; There Should Be At Least 4 Ready-To-Use Bottles Of 55 Ml Each In The Package; The Solution Must Contain Potassium Fluoride At Least < 10.0%; The Solution Should Remain Stable For At Least 29 Days; The Storage Temperature Should Be No Less Than 2°C And No More Than 8°C. The Product Release Date Must Be No Earlier Than 2024; The Supplier Provides Documents Confirming The Compliance Of The Supplied Goods With The Requirements Established By Technical Regulations, Provisions Of Standards Or Other Documents In Accordance With The Legislation Of The Republic Of Kazakhstan, Including A Registration Certificate With The Ministry Of Health Of The Republic Of Kazakhstan, An Iso 13485 Certificate., Tablets Must Be Intended For Incubation Of Samples And Reagents, As Well As For Measuring Fluorescence On The B·R·A·H·M·S Kryptor Compact Plus Device.; The Number Of Tablets In The Package Must Be At Least 60 Tablets; Reaction Tablets Must Have 96 Wells In Each; There Should Be 60 Adhesive Films In The Set; Tablets Must Remain Stable For At Least 7 Days; The Product Release Date Must Be No Earlier Than 2024; The Supplier Provides Documents Confirming The Compliance Of The Supplied Goods With The Requirements Established By Technical Regulations, Provisions Of Standards Or Other Documents In Accordance With The Legislation Of The Republic Of Kazakhstan, Including A Registration Certificate With The Ministry Of Health Of The Republic Of Kazakhstan, An Iso 13485 Certificate., The Buffer Should Be A Concentrate Of Phosphate-Salt Buffer Solution (Pbs), Which Should Be Intended For The Preparation Of Systemic Fluid; The Buffer Must Be Compatible With The Automatic Biochemical Analyzer B•R•A•M•S Kryptor Compact Plus Installed In The Customers Laboratory; The Buffer Should Be In The Form Of A Powder; The Package Must Contain At Least 5 Sachets; Each Bag Must Be At Least 65 Grams; A Bag Of Powder Should Be Diluted In The Ratio Of 1 Bag To 5 Liters Of Distilled Water; The Composition Of The Powder Should Contain Potassium Phosphate In A Concentration Of At Least 25%, Sodium Phosphate In A Concentration Of At Least 50% And Sodium Chloride In A Concentration Of At Least 50%; Ph Should Be In The Range From 6.8 To 7.0; ; A Bag Of Powder Should Be Diluted In The Ratio Of 1 Bag To 5 Liters Of Distilled Water; The Buffer Solution Should Remain Stable For At Least 15 Days; The Storage Temperature Should Be No Less Than 18°C ​​And No More Than 30°C. The Product Release Date Must Be No Earlier Than 2024; The Supplier Provides Documents Confirming The Compliance Of The Supplied Goods With The Requirements Established By Technical Regulations, Provisions Of Standards Or Other Documents In Accordance With The Legislation Of The Republic Of Kazakhstan, Including A Registration Certificate With The Ministry Of Health Of The Republic Of Kazakhstan, An Iso 13485 Certificate., A Set Of Reagents For The Quantitative Determination Of The Determination Of Pregnancy-Associated Protein A Plasma Should Quantitatively Determine The Concentration Of Papp-A (Pregnancy-Associated Protein-A Plasma) In Human Serum. The Set Must Be Compatible With The Automatic Biochemical Analyzer B•R•A•M•S Kryptor Compact Plus Installed In The Customers Laboratory. The Kit Should Consist Of: Ready-To-Use Xl-Conjugate Containing Monoclonal Antibody To Papp-A Conjugated With Xl665, Buffer, Bovine Albumin, Non-Specific Mouse Immunoglobulin And Potassium Fluoride.; Ready-To-Use K-Conjugate Containing A Monoclonal Antibody To Papp-A Conjugated With Europium Cryptate, Buffer, Bovine Albumin, Mouse Non-Specific Immunoglobulins, Potassium Fluoride; Ready-To-Use Diluent Containing Newborn Calf Serum, Sodium Azide, Preservatives: The Set Must Have A Sticker With A Bar Code Containing All The Information Necessary To Register A New Batch Of Reagents; The Number Of Tests In The Set Should Be 75; Sample Type - Serum; The Volume Of The Sample Required For The Analysis Should Be At Least 50 Μl; Incubation Time Should Be No More Than 19 Minutes; The Results Must Be Presented In Mu/L; The Stability Of The Set In The Analyzer (Stability After Opening) Must Be No Less Than 29 Days; The Principle Of Analysis Should Be A Sandwich Method; The Storage Temperature Should Be No Less Than 2°C And No More Than 8°C. The Product Release Date Must Be No Earlier Than 2024; The Supplier Provides Documents Confirming The Compliance Of The Supplied Goods With The Requirements Established By Technical Regulations, Provisions Of Standards Or Other Documents In Accordance With The Legislation Of The Republic Of Kazakhstan, Including A Registration Certificate With The Ministry Of Health Of The Republic Of Kazakhstan, An Iso 13485 Certificate., The Solution Should Be Intended For Flushing The B·R·A·H·M·S Kryptor Compact/Kryptor Compact Plus Liquid System. The Solution Must Be Compatible With The Automatic Biochemical Analyzer B•R•A•M•S Kryptor Compact Plus Installed In The Customers Laboratory; There Should Be At Least 4 Ready-To-Use Bottles Of 55 Ml In The Package; The Solution Must Contain Sodium Hydroxide At Least < 2.0%; The Solution Should Remain Stable For At Least 29 Days; The Storage Temperature Should Be No Less Than 2°C And No More Than 8°C. The Product Release Date Must Be No Earlier Than 2024; The Supplier Provides Documents Confirming The Compliance Of The Supplied Goods With The Requirements Established By Technical Regulations, Provisions Of Standards Or Other Documents In Accordance With The Legislation Of The Republic Of Kazakhstan, Including A Registration Certificate With The Ministry Of Health Of The Republic Of Kazakhstan, An Iso 13485 Certificate., A Set Of Controls For Prenatal Screening Must Be Used To Control The Quality Of The Analysis In The B•R•A•M•S Kryptor Compact Plus Device Installed In The Customers Laboratory; The Package Must Have Three Levels Of Control, 2 Vials Per Level; Each Vial Should Contain A Lyophilized Mixture Of Such Human Antigens As Afp, Free Β-Hcg And Papp-A, Human Blood Serum And A Preservative; A Sticker With A Barcode Must Contain Information About The Batch Of Controls, In Particular, The Values ​​Of The Target Concentrations, The Obtained Values ​​Of The Standard Deviations, And The Acceptable Concentration Ranges; The Package Must Contain Self-Adhesive Labels With A Bar Code Of 32 For Each Control; The Number Of Bottles In The Package Should Be 6; The Principle Of Analysis Should Be A Sandwich Method; The Storage Temperature Should Be No Less Than 2°C And No More Than 8°C. The Product Release Date Must Be No Earlier Than 2024; The Supplier Provides Documents Confirming The Compliance Of The Supplied Goods With The Requirements Established By Technical Regulations, Provisions Of Standards Or Other Documents In Accordance With The Legislation Of The Republic Of Kazakhstan, Including A Registration Certificate With The Ministry Of Health Of The Republic Of Kazakhstan, An Iso 13485 Certificate., Tablets Must Be Intended For Diluting Samples On The B·R·A·H·M·S Kryptor Compact Plus Device; The Number Of Tablets In The Package Must Be At Least 30 Tablets; Tablets For Breeding Should Have 24 Holes In Each; There Should Be 30 Adhesive Films In The Set; Tablets Must Remain Stable For At Least 29 Days; The Product Release Date Must Be No Earlier Than 2024; The Supplier Provides Documents Confirming The Compliance Of The Supplied Goods With The Requirements Established By Technical Regulations, Provisions Of Standards Or Other Documents In Accordance With The Legislation Of The Republic Of Kazakhstan, Including A Registration Certificate With The Ministry Of Health Of The Republic Of Kazakhstan, An Iso 13485 Certificate., The Set Of Reagents For Installation Should Consist Of At Least 3 Bottles With A Calibrator, At Least 2 Orange Bottles Containing Dry Cryptate (Reagent For Setting Up And Testing The Device), A Set Of Stickers With Barcodes And A Set Of Cards For Registering The Specified Reagents In The Software Provision Of The Device. The Set Must Be Compatible With The Automatic Biochemical Analyzer B•R•A•M•S Kryptor Compact Plus Installed In The Customers Laboratory. The Specified Set Must Be Diluted By The Device In The Concentrations And Quantities Specified In The Protocol Of The Device. The Composition Of 1 Set Should Be Enough For Setting Up The Device (Calibrating Test Positions), Verifying The Correctness Of The Dilution Of The Dry Reagent And A Test Run To Determine The Repeatability Of The Results. The Number Of Tests In The Set Should Be No Less Than 75; The Storage Temperature Should Be No Less Than 2°C And No More Than 8°C. The Product Release Date Must Be No Earlier Than 2024; The Supplier Provides Documents Confirming The Compliance Of The Supplied Goods With The Requirements Established By Technical Regulations, Provisions Of Standards Or Other Documents In Accordance With The Legislation Of The Republic Of Kazakhstan, Including A Registration Certificate With The Ministry Of Health Of The Republic Of Kazakhstan, An Iso 13485 Certificate.