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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.
 
DeviceVERSANT & APTIMA HCV RNA QUALITATIVE ASSAY
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
GEN-PROBE
10210 genetic center dr.
san diego, CA 92121
PMA NumberP020011
Supplement NumberS002
Date Received02/23/2010
Decision Date09/17/2010
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 CHANGE IN QUALITY CONTROL SPECIFICATIONS FOR THE HCV CALIBRATORS.
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