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Tender description :
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Open competition: Reagents and consumables for the modular analyzer Cobas Pro (c 503) and Cobas pure (c 303)
Cholesterol cassette - Cholesterol (CHOL) 2600 tests. Reagents for Cobas Pro (c 503) and Cobas pure (c 303) analyzers. Cholesterol CHOL cassette (Cholesterol) for 2600 tests. Purpose: In vitro diagnostic test for the 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; polyethyleneglycol ether of fatty alcohols: 3%; cholesterol esterase (Pseudomonas spec.): = 25 µkat/L (= 1.5 E/mL); cholesterol oxidase (E. coli): = 7.5 µkat/L (= 0.45 E/mL); peroxidase (horseradish): = 12.5 µkat/L (= 0.75 E/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 the refrigerator. Shelf life at 2-8 °C See the expiration date on the cobas c kit label. When used on board the analyzer at 10-15 °C for 8 weeks. Transportation must be in thermal containers with cooling elements at a temperature of 2-8 °C, do not freeze or expose to high temperatures. Calibration is linear over two points, calibration frequency - after lot change. Measurement range 0.1-20.7 mmol/L (3.86-800 mg/dL). The lower limit of detection of the test is 0.1 mmol/L (3.86 mg/dL). Test reproducibility - no more than 0.9%. The supplier is obliged to provide a certificate of origin of the goods. Delivery area - for EU countries. In case of non-compliance of the goods with the technical specifications, replacement of the goods within 3 days after notification.
Lactate Dehydrogenase Cassette - Lactate Dehydrogenase according to IFCC (LDHI) 850 tests. Reagents for Cobas Pro/Pure analyzer. Lactate Dehydrogenase cassette for 850 tests. Purpose: Test for in vitro diagnostics, intended for the quantitative determination of the catalytic activity of LDH (EC 1.1.1.27; L-lactate: NAD+ oxidoreductase) in human serum and plasma on COBAS INTEGRA analyzers. Reagents - working solutions R1 N-methyl-D-glucamine: 400 mmol/L, pH 9.4 (37 °C); lithium lactate: 62 mmol/L; stabilizers SR NAD: 62 mmol/L; stabilizers; preservatives. Ready to use. *Storage and stability. Expiration date at 2-8 °C. See the expiration date on the cobas cassette label. In case of non-compliance of the product with technical specifications, replacement of the product within 3 days after notification. Identification of the reagent using an RFID chip. Each bottle must have an RFID tag with encoding information. Before supplying the reagent, update the reagent database of the analyzer.
Antistreptolysin cassette - Antistreptolysin O (ASLO) 200 tests. Reagents for Cobas Pro/Pure analyzer. Antistreptolysin cassette for 200 tests. Purpose: In vitro diagnostic kit. Designed for the quantitative determination of antibodies to streptolysin O in human serum and plasma on Roche/Hitachi cobas c analyzers. Reagents - 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. Preparation of the working solution of the reagent. Ready to use. Before installing the cobas c cassette on the analyzer, its contents must be thoroughly mixed. Before use, gently invert the reagent cassette several times for mixing. Storage and stability shelf life at 2-8 °C: See expiration date on the cobas c pack. Shelf life of opened reagent in the refrigerator on the analyzer: 12 weeks. In case of non-compliance of the product with technical specifications, replacement of the product within 3 days after notification. Identification of the reagent using an RFID chip. Each bottle must have an RFID tag with encoded information. Before supplying the reagent, update the analyzerreagent database.
Bilirubin Direct cassette - Bilirubin Direct (BILD) 1000 tests. Reagents for Cobas Pro/Pure analyzer. Bilirubin Direct cassette for 1000 tests. Purpose: In vitro test for the quantitative determination of direct bilirubin concentration in human serum and plasma on Cobas c systems. Reagents - working solutions: R1 Phosphoric acid: 85 mmol/L; HEDTA: 4.0 mmol/L; NaCl: 50 mmol/L; detergent; pH 1.9 SR 3,5-Dichlorophenyl diazonium: 1.5 mmol/L; pH 1.3. The reagent is ready to use. Storage and stability: Shelf life at 2-8 °C See expiration date on the cobas c cassette label. In case of non-compliance of the product with technical specifications, the product can be replaced within 3 days after notification. Identification of the reagent using an RFID chip. Each bottle must have an RFID tag with encoding information. Before supplying the reagent, update the analyzerreagent database.
Reagents for the Cobas Pro/Pure analyzer. Cassette for determining Aspartate Aminotransferase for 800 tests. Purpose: In vitro diagnostic test for the quantitative determination of aspartate aminotransferase (AST) in human serum and plasma on Roche/Hitachi cobas c analyzers with pyridoxal phosphate activation. Reagents - working solutions R1 TRIS buffer: 264 mmol/L, pH 7.8 (37 °C); L aspartate: 792 mmol/L MDH (bacterial): = 24 µkat/L; LDH (bacterial): = 48 µkat/L; albumin (bovine): 0.25%; preservative R2 Pyridoxal phosphate: 730 µmol/L; preservative R3 NADH (yeast): = 1.7 mmol/L; 2-oxoglutarate: 94 mmol/L; preservative. Ready to use storage and stability ASTLP Storage period at 2-8 °C: See expiration date on the packaging of the cobas c pack cassette. Storage period of opened reagent in the refrigerator on board the analyzer: 12 weeks. In case of non-compliance of the product with the technical specifications, replacement of the product within 3 days after notification. Identification of the reagent using an RFID chip. Each bottle must have an RFID tag with encoded information. Before supplying the reagent, update the reagent database of the analyzer.
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