Poland - Laboratory reagents

Description

The subject of the contract is successive supply of reagents, tests and small laboratory equipment for the Department of Laboratory and Microbiological Diagnostics with the Blood Bank and the Department of Pathology of the Specialist Hospital in Kościerzyna Sp. z o.o., divided into 47 tasks. The Contracting Authority does not provide for supplementary orders referred to in art. 67 section 1 item 6 and 7 of the PPL Act.
Task 1 - Tests and reagents. Task 2 - IMMUNOENSEMENTAL TESTS Task 3 - READY BACKGROUNDS The above mentioned Economic Operator will be requested to submit the following statements or documents confirming that the supplies offered meet the requirements specified by the Contracting Authority:1)Certificate of Quality Management System Registration at the production and product level - ISO 13485 for medical devices and at the administrative level e.g. ISO 90012)Registration at the registration office for all products;3)Methodologies for each offered item;4)For chromogenic substrates, leaflets containing colour photographs with a description of the appearance of colonies on the plates and the method of performing the seeding and interpretation of reading. The substrate safety data sheet should contain the following information in Polish: composition, properties and intended use of the substrate, procedure, incubation conditions, description of the growing colonies, interpretation of results, storage conditions of the substrate - task 3 item. 7, 8, 9, 11, 13, 14, 16, 23;5)Quality control certificate for each batch of supplied medium with the signature of the control person or information about electronic process validation - task 3 item. 7, 8, 9, 11, 13, 14, 16, 23;6)CE Declaration of Conformity;7)Current methodology attached to the samples:- task 3 item 2, 4, 8, 9, 16, 23, 25, 37, 38, 39, 41.8)Samples with a list of submitted samples (according to the template attached to the ToR), item 2, 4, 8, 9, 16, 23, 25, 37, 38, 39,41 -10 each. Task 4 - READY INSURANCE FOR MIKROBIOLOGICAL WATER EXAMINATION The highest-ranked Contractor shall be requested to submit the following statements or documents confirming that the offered deliveries meet the requirements specified by the Contracting Authority:1)Current methodology attached to the samples:- Task 4 item 1,3,7,8,9,15.2)Certificate of Quality Management System Registration at the production and product level ISO 13485 for products and at the administrative level, e.g. ISO 9001;3)Certificates of quality control for each series of delivered substrate with the signature of the inspector or information about electronic process validation - task 4 item 1,3,4,7,9,15;4)Samples together with a list of delivered samples (according to the template attached to the ToR), item 1,3,7,8,9,15 - 10 each. TASK 5 - ANTI-TYPE PACKAGES TO THE BECTON DICKINSON DISPLAYERS TASK 6 - TASKS, TESTs, REAGENTS TASK 7 - DISPLAYERS The highest-ranking Economic Operator shall be invited to submit the following statements or documents confirming that the offered deliveries meet the requirements specified by the Contracting Authority:1)Methodology confirming that the contact method in surface inspection is in accordance with the applicable standards ISO 14698-1, ISO 18593 - Task 7;2)Methodology confirming that the substrate must contain neutralizing agents that inactivate residues of disinfectants: aldehydes and phenolic radicals, quaternary ammonium base radicals, hexachlorophene, mercury derivatives, halogen radicals, chlorhexidine. TASK 8 -SPORALE, REAGENTS FOR IDENTIFYING E.COLI EPEC, REAGENTS FOR IDENTIFYING SALMONELLA SPP. SGIGELLA TASK 9 - REFERENCE STRAINS TASK 10 - TEST STRIPS FOR DETERMINING MIC VALUES FOR ANTIMICROBIAL DRUGS TASK 11 - MICROBIOLOGICAL TESTS TASK 12 - COVER SLIDES AND BASIC TASK 13 - LABORATORY GLASS AND DISPOSABLE ASSORTMENT TASK 14 - SMALL LABORATORY EQUIPMENT TASK 15 - GASMETERY TASK 16 - TASK 17 - TULIPAN' TASK 18 - FAST IMMUNOCHEMICAL TESTINGS The Contractor assessed above shall be invited to submit the following statements or documents confirming that the offered supplies meet the requirements specified by the Contracting Authority:1)Methodology in the Polish language for each test - Task 18;2)Document confirming the notification of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products that the product has been introduced into the territory of the Republic of Poland Task 19 - Fast IMMUNOCHEMICAL TESTS The Contractor of the highest rated Economic Operator shall be requested to submit the following statements or documents confirming that the offered supplies meet the requirements specified by the Contracting Authority:1) Methodology in the Polish language;2) Document confirming the notification of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products that the product has been introduced into the territory of the Republic of Poland. TASK 20 Vacuum urine collection kit. TASK 21 - Small laboratory equipment. TASK 22 - ANALYTICAL TESTS FOR READING WITH HACH-LANGE EQUIPMENT. TASK 23 - RAPID IMMUNOCHEMICAL TESTS. TASK 24 - CARB DIAGNOSTIC TESTS. TASK 25 - LABORATORY EQUIPMENT. Task 26 - APPLICATIONS OF THE APPLICANT The Contractor will be requested to submit the following statements or documents confirming that the supplies offered meet the requirements specified by the Purchaser:1) Instructions or other document confirming the absence of cross-reaction with other IgG, IgA, IgM immunoglobulins;2) Methods in Polish. TASK 26 - IMMUNOCHROMATOGRAPHIC TESTS TASK 28 - TASK 29 - IMMUNOCHROMATOGRAPHIC TESTS The Contractor who has been assessed above will be requested to submit the following statements or documents confirming that the supplies offered meet the requirements specified by the Awarding Entity:1) Certificate of Quality Management System Registration at the production and product level ISO 13485 for medical devices and at the administrative level, e.g.: 1) Instructions or other document confirming no cross-reaction with other immunoglobulins of IgG, IgA, IgM; 2) Methods in Polish language. ISO 9001. TASK 30 - GENETIC TESTS FOR GENEXPERT APPARATUS. TASK 31 - GENETIC TESTS FOR THE BIOFIRE APPARATUS. TASK 32 - TESTS TO BE READ WITH QUANTUM BLUE (GENLOX) READER. TASK 33 - GENETIC TESTS TO ELITE INGENIUS APPARATUS. TASK 34 - CHEMICAL REAGENTS. TASK 35 - THINNER AOB-1. TASK 36 - FAST DIAGNOSTIC KITS FOR HISTOCHEMICAL STAINING. TASK 37 - HISTOPATHOLOGICAL PARAFFIN AND ADHESIVE FOR MANUAL SEALING OF MICROSCOPIC PREPARATIONS. TASK 38 - TAPE FOR AUTOMATIC SEALERS. TASK 39 - HISTOPATHOLOGICAL TAPES. TASK 40 - TISSUE PAPER FOR CYTOTEXTILES TASK 41 - ARCHIVING TASK 42 - BASIC AND COVER GLASSES TASK 43 - CONTAINERS FOR TRANSPORTING SURGICAL MATERIAL. TASK 44 - MICROTOME SCISSORS TASK 45 - SMALL LABORATORY EQUIPMENT TASK 46 - CONSUMABLES FOR BAR CODE PRINTERS AND 2D. TASK 47 - A SET OF REAGENTS AND A SYSTEM FOR PERFORMING CYTOLOGY ON A LIQUID MEDIUM (LBC) ON A SLIDE APPARATUS.

Opportunity closing date

06 October 2020

Value of contract

to be confirmed