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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 supplement. The device description may have changed. Be sure to look at the original PMA to get an up-to-date view of this device.
 
Trade NameAMPLICOR HCV TEST,VERSION 2.0
Classification Nameassay,hybridization and/or nucleic acid amplification for detection of hepatitis c rna,hepatitis c virus
Generic Nameroche amplicor hepatitis c virus (hcv) test version 2.0
ApplicantROCHE MOLECULAR SYSTEMS, INC.
PMA NumberP000010
Supplement NumberS003
Date Received04/12/2004
Decision Date05/06/2004
Product Code
MZP[ Registered Establishments with MZP ]
Advisory Committee Microbiology
Supplement Type30-day notice
Supplement Reason process change: manufacturing
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Incorporation of a terminal 0. 2 um filtration step to the avidin-horseradish peroxidase (hrp) bgg conjugate reagent manufacturing process. The submission identified the change for which the approval is being requested and provides the rationale for the change.
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