Abbott RealTime HBV

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 polymerase chain reaction (PCR) assay for the quantitation of Hepatitis B Virus (HBV) DNA in human plasma or serum from HBV‑infected individuals. The Abbott RealTime HBV assay is intended for use in conjunction with clinical presentation and other laboratory markers as an indicator of disease prognosis and for use as an aid in assessing viral response to antiviral treatment as measured by changes in plasma or serum HBV DNA levels. This assay is not intended for use as a screening test for HBV or as a diagnostic test to confirm the presence of HBV infection.

Product summary:

Models: Abbott m2000sp - G Series - 9K14-01, Abbott m2000sp - E Series - 9K14-02, Abbott m2000rt - 9K15-01, Abbott Real Time HBV Calibrator Kit - 2G34-70, Abbott Real Time HBV Control Kit - 2G34-80, Abbott Real Time HBV Amplification Reagent Kit - 2G34-90, Abbott m2000rt Software Release 6.0 - 50-148401, Abbott m2000sp Software Release 6.0 - 50-148400, Abbott RealTime HBV m2000 System ROW Combined Application CD-ROM v4 - 8L35-04, 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:

2010-09-15