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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.
 
DeviceAMPLICOR HCV TEST V2.0/COBAS AMPLICOR HCV TEST V2.0
Generic NameAssay, hybridization and/or nucleic acid amplification for detection of hepatitis c rna,hepatitis c virus
Regulation Number866.3170
ApplicantRoche Molecular Systems, Inc.
4300 HACIENDA DR.
PLEASANTON, CA 94588-0900
PMA NumberP000010
Supplement NumberS020
Date Received03/01/2011
Decision Date03/22/2011
Withdrawal Date 06/30/2014
Product Code MZP 
Advisory Committee Microbiology
Supplement Type30-Day Notice
Supplement Reason Process Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
DISCONTINUATION OF FINAL BULK TESTING REQUIREMENTS FOR BULK QUANTITATION STANDARD (QS) AND INTERNAL CONTROL (IC) REAGENTS FOR 17 QS/IC PRODUCTS USED WITH THE ASSOCIATED ASSAYS.
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