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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 IMMUNOASSAY, ELECSYS PRECICONTROL ANTI-HCV FOR USE ON COBAS E411 IMMUNOSSAY ANALYZER
Generic NameAssay, enzyme linked immunosorbent, hepatitis c virus
ApplicantROCHE DIAGNOSTICS CORP.
9115 HAGUE RD.
INDIANAPOLIS, IN 46250
PMA NumberP090007
Supplement NumberS015
Date Received02/16/2016
Decision Date03/16/2016
Reclassified Date 12/22/2021
Product Code MZO 
Advisory Committee Microbiology
Supplement Type30-Day Notice
Supplement Reason Process Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
Relocation of manufacturing activities for the purification and production of antibodies and proteins and for the lyophilization of raw materials and addition of new lyophilization equipment.
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