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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, VERSION 2.0
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 NumberS010
Date Received05/24/2007
Decision Date02/06/2008
Withdrawal Date 06/30/2014
Product Code MZP 
Advisory Committee Microbiology
Supplement Type135 Review Track For 30-Day Notice
Supplement Reason Process Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
APPROVAL FOR A MODIFICATION TO THE TESTING USED TO RELEASE TWO OLIGONUCLEOTIDE INTERMEDIATES FOR FURTHER MANUFACTURE.
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