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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 ON COBAS E 601
Classification Nameassay,enzyme linked immunosorbent,hepatitis c virus
ApplicantROCHE DIAGNOSTICS CORP.
PMA NumberP090008
Supplement NumberS005
Date Received08/29/2011
Decision Date11/17/2011
Product Code
MZO[ Registered Establishments with MZO ]
Advisory Committee Microbiology
Supplement Type135 review track for 30-day notice
Supplement Reason process change: manufacturing
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for changes to the manufacturing procedure for the bead coating process of the intermediate storage form of elecys coated microparticles.
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