Tenders Are Invited For Diagnostic Supplies – Purchase Of Kits For Screening Newborn Tests For Congenital Hypothyroidism (Hypothyroidism) Using Immunofluorometric Method (Feia/Fia).

Diagnostic Supplies – Purchase Of Kits For Screening Newborn Tests For Congenital Hypothyroidism (Hypothyroidism) Using Immunofluorometric Method (Feia/Fia).. I. The Subject Of The Order Is The Supply Of Kits For Newborn Screening Tests For Congenital Hypothyroidism (Chf) Using The Immunofluorimetric Method (Feia/Fia) On Microplates, In The Total Number Of 715,200 Tests, The Kits Must Contain All Reagents And Components Necessary To Perform Newborn Screening Tests (In Accordance With The Manufacturers Instructions) And Paper For Blood Collection - Standard 903 According To The Pattern (With A Barcode). – In The Code 39 Standard), In The Number Of 595,000 Pieces, Subject To § 1 Section 4 Of The Draft Provisions Of The Agreement (Hereinafter Referred To As Ppu) In The Event Of A Reduction In The Expected Number Of Childbirths, On The Terms Specified In The Content Of The Swz. Ii. Pursuant To Art. 256 Of The Public Procurement Law. The Contracting Authority May Cancel The Contract Award Procedure Well Before The Deadline For Submitting Offers If Circumstances Occur That Make Further Conduct Of The Procedure Unjustified. Iii. Pursuant To Art. 257 Of The Public Procurement Law. The Contracting Authority May Invalidate The Contract Award Procedure If The Public Funds That The Contracting Authority Intended To Use To Finance All Or Part Of The Contract Were Not Awarded To It. Iv. The Order Must Be Completed In Accordance With The Requirements Specified In The Swz And In The Draft Provisions Of The Agreement. V. Subject Measures Of Evidence: 1. Pursuant To Art. 105 And Art. 106 Of The Public Procurement Law. In Order To Confirm Compliance Of The Offered Supplies With The Requirements, Features Or Criteria Specified In The Description Of The Subject Of The Order Or The Offer Evaluation Criteria Or Requirements Related To The Implementation Of The Order, The Ordering Party Requests The Contractors To Present The Following Documents: 1.1. Declaration Of Conformity Issued By The Product Manufacturer, 1.2. Ce-Ivd/Ce-Ivdr Certificate Of Certificates Of Notified Bodies That Participated In The Product Conformity Assessment Procedure - If Applicable 1.3. Declaration Of Being/Not Being Subject To The Obligation To Submit/Notify Data About The Device To The President Of The Office For Registration Of Medicinal Products, Medical Devices And Biocidal Products Pursuant To Art. 58 Section 1 Or Art. 58 Section 2 Of The Act Of May 20, 2010 On Medical Devices (Journal Of Laws Of 2021, Item 1565, As Amended), In Connection With Art. 138 Of The Act Of April 7, 2022 On Medical Devices (Journal Of Laws Of 2022, Item 974, As Amended) And Alternatively A) If The Bidder Is A Manufacturer Of The Device Based In The Territory Of The Republic Of Poland, Submitting A Declaration Of Compliance With The Obligation To Submit A Notification Pursuant To Art. 58 Section 1 Or Art. 58 Section 2 Of The Act Of May 20, 2010 On Medical Devices (Journal Of Laws Of 2021, Item 1565, As Amended), In Connection With Art. 138 Of The Act Of April 7, 2022 On Medical Devices (Journal Of Laws Of 2022, Item 974, As Amended); B) If The Bidder Is An Importer Or Distributor Who Is The First To Introduce The Product Into The Territory Of The Republic Of Poland, Submit A Declaration Of Compliance With The Obligation To Notify Pursuant To Art. 58 Section 3 Of The Act, Including The Declaration