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U.S. Department of Health and Human Services

Premarket Approval (PMA)

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Note: this medical device record is a supplement. The device description may have changed. Be sure to look at the original PMA to get an up-to-date view of this device.
 
Trade NameELECSYS ANTI-HCV IMMUNOASSAY
Classification Nameassay,enzyme linked immunosorbent,hepatitis c virus
ApplicantROCHE DIAGNOSTICS CORP.
PMA NumberP090008
Supplement NumberS006
Date Received11/01/2011
Decision Date04/25/2012
Product Code
MZO[ Registered Establishments with MZO ]
Advisory Committee Microbiology
Supplement Typenormal 180 day track
Supplement Reason change design/components/specifications - component
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for the extension of the elecsys anti-hcv immunoassay and precicontrol anti-hcv immunoassay onto the cobas e 602 immunoassay analyzer. The device, as modified, will be marketed under the trade name elecsys anti-hcv immunoassay and is indicated for: elecsys anti-hcv immunoassay - the elecsys anti-hcv immunoassay is an in vitro diagnostic test for the qualitative detection of total antibodies to hepatitis c virus (anti-hcv) in human serum or plasma (potassium edta, lithium heparin and sodium heparin). Assay results, in conjunction with other laboratory results and clinical information, may be used to aid in the presumptive diagnosis of hcv infection in persons with signs and symptoms of hepatitis and in persons at risk for hepatitis c infection. This test does not determine the state of infection or associated disease. The electrochemiluminescence immunoassay "eclia" is intended for use on cobas e 601 and cobas e 602 immunoassay analyzers.
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