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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 PMA supplement. A supplement may have changed the device description/function or indication from that approved in the original PMA. Be sure to look at the original PMA record for more information.
 
DeviceELECSYS ANTI-HCV ON MODULAR ANALYTICS E170
Classification Nameassay,enzyme linked immunosorbent,hepatitis c virus
Generic Nameassay,enzyme linked immunosorbent,hepatitis c virus
Applicant
ROCHE DIAGNOSTICS CORP.
9115 hague rd.
indianapolis, IN 46250
PMA NumberP090009
Supplement NumberS008
Date Received02/29/2012
Decision Date03/28/2012
Product Code
MZO[ Registered Establishments with MZO ]
Advisory Committee Microbiology
Supplement Type30-day notice
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
TRANSFER OF THE REWORK ACTIVITIES FOR THE ELECSYS REAGENT KITS FROM BUILDING R TO BUILDING W2 ON THE INDIANAPOLIS CAMPUS.
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