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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.
 
DeviceCOBAS AMPLICOR HCV TEST, VERSION 2.0
Classification Nameassay,hybridization and/or nucleic acid amplification for detection of hepatitis c rna,hepatitis c virus
Generic Nameassay,hybridization and/or nucleic acid amplification for detection of hepatitis c rna,hepatitis c virus
Applicant
Roche Molecular Systems, Inc.
4300 hacienda dr.
pleasanton, CA 94588-0900
PMA NumberP000012
Supplement NumberS014
Date Received05/24/2007
Decision Date02/06/2008
Product Code
MZP[ Registered Establishments with 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 Product No
Approval Order Statement 
APPROVAL FOR A MODIFICATION TO THE TESTING USED TO RELEASE TWO OLIGONUCLEOTIDE INTERMEDIATES FOR FURTHER MANUFACTURE.
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