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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 COBAS E 601
Classification Nameassay,enzyme linked immunosorbent,hepatitis c virus
ApplicantROCHE DIAGNOSTICS CORP.
PMA NumberP090008
Supplement NumberS007
Date Received11/21/2011
Decision Date12/14/2011
Product Code
MZO[ Registered Establishments with MZO ]
Advisory Committee Microbiology
Supplement Type30-day notice
Supplement Reason process change: manufacturing
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Change to scalable lot sizes in the component manufacturing process of elecsys® anti-hcv immunoassay and elecsys® precicontrol anti-hcv and a change in the lyophilisation process.
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