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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 & ELECSYS PRECICONTROL ANTI-HCV FOR USE ON THE ROCHE COBAS E 411 IMMUNOASSAY ANALYZER
Classification Nameassay,enzyme linked immunosorbent,hepatitis c virus
ApplicantROCHE DIAGNOSTICS CORP.
PMA NumberP090007
Supplement NumberS001
Date Received07/29/2010
Decision Date09/23/2010
Product Code
MZO[ Registered Establishments with MZO ]
Advisory Committee Microbiology
Supplement Typenormal 180 day track
Supplement Reason labeling change - instructions
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for a modification to the device labeling to add a claim defining the immunoassay cutoff-index above which supplemental recombinant immunoblot assay testing is not required.
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