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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 HCV RNA QUALITATIVE ASSAY AND THE 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 NumberS001
Date Received05/01/2009
Decision Date05/22/2009
Product Code
MZP[ Registered Establishments with MZP ]
Advisory Committee Microbiology
Supplement Type30-day notice
Supplement Reason process change - manufacturer/sterilizer/packager/supplier
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
CHANGE OF THE ACTIVATOR USED IN THE SYNTHESIS OF DNA OLIGONUCLEOTIDES FROM 1-H TETRAZOLE TO 5-ETHYLTHIO 1-H TETRAZOLE (ETT) AND THE ADDITION OF SIGMA-ALDRICH (SAFC) AS A SECONDARY SUPPLIER OF THE NEW ACTIVATOR (ETT).
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