Tenders Are Invited For For Successive Deliveries Of Reagents And Consumables For Laboratory Diagnostics With The Lease Of An Analyzer To Rkz For The Needs Of The Central Laboratory Of Spzzoz Lipsko

1. The Subject Of The Order Is The Successive Deliveries Of Reagents Along With The Lease Of An Analyzer Enabling The Determination Of Rkz Parameters For The Needs Of The Central Laboratory Of The Independent Public Complex Of Health Care Facilities In Leipzig. A Detailed Description Of The Subject Of The Order, As Well As The Terms Of Delivery, Service And Staff Training Are Set Out In Annexes No. 2, 3, 4 And 4A To Swz2. The Subject Of The Order (Being Medical Devices: Analyzers, Reagents, Calibrators, Control Materials, Consumables And Consumables), Must Be Authorized For Trading And Use In Accordance With The Act Of April 7, 2022 On Medical Devices (Journal Of Laws Of 2022, Item 974), And Must Also Be Marked With The Ce Mark And Have A Valid Ce Declaration Of Conformity. The Subject Of The Order (Reagents, Calibrators, Control Materials And Consumables And Consumables) Being Medical Devices For In Vitro Diagnostics Must Meet The Requirements Of The Current Regulation Of The Minister Of Health On Essential Requirements And Procedures For Assessing The Conformity Of Medical Devices For In Vitro Diagnostics And Be Marked With The Ce Mark And Have A Valid Ce Declaration Of Conformity. The Subject Of The Order Is A Chemical Substance Or Its Mixture Within The Meaning Of The Act Of February 25, 2011 On Chemical Substances And Their Mixtures (Journal Of Laws No. 63, Item 322 Of 2011, As Amended) Must Have Safety Data Sheets For The Chemical Substance Or Its Mixture.3. The Offered Device (Analyzer) Must Comply With The Description Contained In Annex 3 To The Swz, Complete And After Installation, Ready To Start Working, Without Any Additional Purchases. The Offered Analyzer Should Be Integrated With The Infinity It System Of Roche Diagnostics Polska Sp. Owned By The Ordering Party. Z O. O. 4. After Putting The Subject Of The Order Into Operation And Accepting It By The Ordering Party, Confirmed By The Delivery And Acceptance Protocol, The Contractor Is Obliged To Conduct Training In The Operation Of The Device For Medical Staff At Its Own Expense.