Roche Diagnostics COBAS INTEGRA Tina-quant D-Dimer Gen 2

Country: Singapore

Language: English

Source: HSA (Health Sciences Authority)

Available from:

Roche Diagnostics Asia Pacific Pte Ltd

Class:

Class B IVD

Manufactured by:

Roche Diagnostics GmbH

Therapeutic area:

Hematology

Therapeutic indications:

Roche Diagnostics COBAS INTEGRA Tina-quant D-Dimer Gen.2 is an in vitro test for the quantitative immunological determination of fibrin degradation products (D-Dimer and X-oligomers) in human plasma on COBAS INTEGRA systems.

Product summary:

Device System Info:[Device with measuring function], [System or Procedure Pack], IVD system with analyzers included; Models: Tina-quant D-Dimer Gen.2 - 04912551190, D-dimer Gen.2 Calibrator - 05050901190, D-Dimer Gen.2 Control I/II - 05050936190, Cleaner - 20754765322, CLEAN Cleaner Cassette - 20764337322, NaCl Diluent 9% - 20756350322, SI2 Serum Index Gen.2 - 04489365190, SDR II COBAS FP Sample Dilution Reagent II - 20720720322, MULTI Single use reagent carrier - 04593138190, Cup Sample White with hole - 21045318001, Cup Sample Blue with hole - 21044869001, Cuvette COBAS Integra - 21043862001, COBAS INTEGRA 400 plus - 03245233001, SW v3.5.2 - 05636957001, SW v3.4.4 - 05215242001, Waste Container COBAS Integra 400 - 21046179001

Authorization date:

2013-09-12