Devices

COBAS AmpliPrep / COBAS TaqMan HCV Test, CEIVD

Model / Serial
03568547190; All lots
Product Classification
Immunology and Microbiology Devices
Device Class
3
Implanted device?
No
Distribution
USA (nationwide) and countries of: Australia, Austria, Azerbaijan, Belgium, Brazil, Canada, China, Croatia, Czech Republic, Egypt, Finland, France, Germany, Ghana, Greece, Hong Kong, India, Israel, Italy, Japan, Kuwait, Luxembourg, Malaysia, Mongolia, Netherlands, New Zealand, Norway, Poland, Romania, Saudia Arabia, Sinagpore, Slovakia, Slovenia, South Africa, South Korea, Spain, Sweden, Switzerland, Thailand, Turkey, United Arab Emirates and United Kingdom.
Product Description
COBAS¿ AmpliPrep / COBAS¿ TaqMan¿ HCV Test, CE-IVD || The COBAS¿ AmpliPrep/COBAS¿ TaqMan¿ HCV Test is an in vitro nucleic acid amplification test for the quantitation of Hepatitis C Virus (HCV) RNA in human plasma or serum using the COBAS¿ AmpliPrep Instrument for automated specimen processing and the COBAS¿ TaqMan¿ Analyzer or the COBAS¿ TaqMan¿ 48 Analyzer for automated amplification and detection. The Test is intended for use in conjunction with clinical presentation and other laboratory markers of HCV infection for the clinical management of patients with chronic HCV.
Manufacturer
Roche Molecular Systems, Inc.
1 Event
- Recall of COBAS AmpliPrep / COBAS TaqMan HCV Test, CEIVD

Manufacturer

Roche Molecular Systems, Inc.

Manufacturer Address
Roche Molecular Systems, Inc., 1080 US Highway 202 South, Somerville NJ 08876-3733
Manufacturer Parent Company (2017)
Roche Holding AG
Source
USFDA

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