Arbeitsanleitung - Milenia Biotec GmbH

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- 2 - Explanation of Symbols Symbols (E) Symbole (D) Explanation Erklärung Symbols (E) Symbole (D) Explanation Erklärung Use by Verwendbar bis Contains sufficient for Inhalt ausreichend für In vitro diagnostic medical device In-vitro Diagnostika Manufacturer Hersteller Batch code Chargenbezeichnung For IVD performance evaluation only Nur zur IVD Leistungsbewertung REF Catalogue number Katalognummer Consult Instructions for use Gebrauchsanweisung beachten Storage conditions Lagerungsbedingungen Consult attended documents Begleitdokumente beachten Milenia Biotec, Versailler Straße 1, D-35394 Gießen Milenia QuickLine CRP (MQLRP)
- 3 - Materials Provided,- Storage and Stability Preparation Storage at Shelf life Components Cat.-No. Content CRP Test Unit: MQSRP s 30 ready to use 2 - 8 °C membrane coated with Use monoclonal (mouse) anti-hCRP immediately antibody; monoclonal (mouse) after opening anti-hCRP antibody conjugated the foil pouch! to gold particles CRP/ hsCRP Chase Buffer: PBS-Buffer, pH 7.4 This bag contains 30 Transfer pipettes 10 µL, disposables Certificate of Analysis MQCBC 1 vial with 3 ml (yellow cap) in the closed foil pouch until expiration date ready to use 2 - 8 °C until expiration date MQP1030 30 see procedure p.5 until expiration date CoA- MQLRP Material Safety Data Sheets are available on request (look as well www.milenia-biotec.de). Intended Use 1 • For in vitro diagnostic use. • Milenia ® QuickLine CPR is designed for semi quantitative measurement of human CRP in whole blood and serum Materials Required But Not Supplied Pipet and tips: 5 µL (serum samples) Specimen Collection and Preparation Whole blood: capillary blood, venous blood, or serum. Avoid hemolysis; separate serum from blood cells within two hours. Whole Blood: avoid blood from clotting e.g with anticoagulants like heparin, EDTA; no citrate. Volume Required Whole blood: 10 µL Serum: 5 µL Warnings and Precautions • Read these instructions and the Milenia ® POCScan Reader Manual carefully before performing the test. Follow them step by step! • Store reagents at 2 - 8° C! • Do not use the kit after expiration date! • Do not use test unit if foil pouche is damaged! • Protect test units from moisture! • Compare batch code of your kit and the given batch code in your reader; if necessary: change batch code and parameters. (s. Milenia ® POCScan Reader Manual –‘Enter Test Parameters’) • Do not interchange components of packages of different batch codes! • All samples, used units, pipettes, tips, and other contaminated material should be handled carefully and as potentially infectious. • For professional users. Milenia Biotec, Versailler Straße 1, D-35394 Gießen Milenia QuickLine CRP (MQLRP)
Seite 1: CRP Lateral Flow Immunoassay for se
Seite 5 und 6: - 5 - Test Procedure Preparation:
Seite 7 und 8: - 7 - CRP Lateral Flow Immunoassay
Seite 9 und 10: - 9 - Kitbestandteile, Lagerung und
Seite 11 und 12: - 11 - Testdurchführung Vorbereitu

Arbeitsanleitung - Milenia Biotec GmbH

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