Abbott RealTime HCV Genotype II

Country: Singapore

Language: English

Source: HSA (Health Sciences Authority)

Available from:

ABBOTT LABORATORIES (SINGAPORE ) PRIVATE LIMITED

Class:

Class C IVD

Manufactured by:

Abbott Molecular Inc

Therapeutic area:

Microbiology

Therapeutic indications:

It is an in vitro reverse transcription-polymerase chain reaction (RT-PCR) assay for determining the genotype(s) of hepatitis C virus (HCV) in plasma and serum from HCV-infected individuals. The Abbott RealTime HCV Genotype II is not for screening blood, plasma, serum or tissue donors for HCV, or to be used as a diagnostic test to confirm the presence of HCV infection in donated blood, plasma, serum or tissue.

Product summary:

Models: Abbott m2000sp - G Series - 09K14-01, Abbott m2000sp - E Series - 09K14-02, Abbott m2000rt - 09K15-01, Abbott Real Time HCV Genotype II Amplification reagent kit - 08K24-90, Abbott Real Time HCV Genotype II Internal Control - 8K24Y, Abbott Real Time HCV Genotype II Amplification Reagent Pack A - 8K24 - Reagent Pack A, Abbott Real Time HCV Genotype II Amplification Reagent Pack B - 8K24 - Reagent Pack B, Abbott Real Time HCV Genotype II Amplification Reagent Pack C - 8K24 - Reagent Pack C, Abbott Realtime HCV Genotype II Control kit - 08K24-80, Abbott Real Time HCV Genotype II Negative Control - 8K24Z, Abbott Real Time HCV Genotype II Positive Control - 8K24W, Abbott RealTime HCV Genotype II m2000 ROW System Combined Application CD-ROM Version 4.0 - 08L36-04, ABBOTT mSample Preparation System Reagents - 04J70-24, Abbott m2000rt Software Release 6.0 - 50-148401, Abbott m2000sp Software Release 6.0 - 50-148400, Abbott m2000sp Software Release 8.0 - 50-148393, Abbott m2000rt Software Release 8.0 - 50-148392, Abbott m2000sp Software Release 8.1 - 50-148440, Abbott m2000rt Software Release 8.1 - 50-148441

Authorization date:

2011-03-01