البلد: روسيا البيضاء
اللغة: الروسية
المصدر: Министерством здравоохранения Республики (Центр экспертиз и испытаний в здравоохранении)
DiaMed GmbH, ШВЕЙЦАРИЯ
изделия медицинского назначения
DiaMed GmbH
2022-10-26
6. РУКОВОДСТВО ПОЛЬЗОВАТЕЛЯ ИЗДЕЛИЯ МЕДИЦИНСКОГО НАЗНАЧЕНИЯ 27 1/4 ID-Titration Solution English B009360 v.01 2020-10-13 Product-Identification: 05780 ˝ID-Titration Solution˝ 10 x 10 ml . . . . . . . . . . . . o 009360 INTENDED USE The ˝ID-Titration Solution˝ is a dilution medium intended to be used for the titre determination of antibodies in patient and donor samples with the ID-System. The ˝ID-Titration Solution˝ is suitable for manual and automated systems. SUMMARY The ˝ID-Titration Solution˝ is a standardized, antibody-free, BSA based Solution for preparing serial twofold dilutions of plasma/ serum samples. PRINCIPLE OF TEST(S) Serial dilution is a method to perform successive sequential dilutions of a known volume. The desired dilution or dilutions may then be tested against appropriate red blood cells as required. REAGENT Standardized antibody-free BSA based Solution. Preservatives: The antibiotics trimethoprim and sulfamethoxazole. MATERIAL PROVIDED ˝ID-Titration Solution˝ MATERIAL REQUIRED BUT NOT PROVIDED (According to your local license) • ID-Card ˝LISS/Coombs˝, Id-n°: 50531 • ID-Card ˝Coombs Anti-IgG˝, Id-n°: 50540 • ID-Card ˝NaCl, Enzyme and Cold Agglutinins˝, Id-n°: 50520 • Reagent red blood cells of the ID-System • Pipette and tips • Suspension tubes • D-Incubator • D-Centrifuge • IH-500 and ˝ID-Titration Rack˝, Id-n°: 05770 For the use of other reagents and/or instruments, laboratories must follow their approved validation procedures. STORAGE AND HANDLING • Store at 2–8 °C. • Stability: see expiry date on label. • Once opened and if handled in accordance with Good Laboratory Practice (GLP) principles and stored correctly, each vial may be used for a maximum of 4 weeks. 28 2/4 ID-Titration Solution English B009360 v.01 2020-10-13 WARNINGS AND PRECAUTIONS • For _in vitro_ diagnostic use. • Strict adherence to the procedures and recommended equipment are essential. The equipment should be checked اقرأ الوثيقة كاملة