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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.
Classification Nameassay,enzyme linked immunosorbent,hepatitis c virus
Generic Nameantibody to hepatitis c virus
PMA NumberP970027
Supplement NumberS006
Date Received02/11/2008
Decision Date02/22/2008
Product Code
MZO[ Registered Establishments with MZO ]
Advisory Committee Microbiology
Supplement Type Special Supplement
Supplement Reason labeling change - instructions
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for labeling modifications that correct the error in the axsym anti-hcv package insert (list number 5c36) under reatents section. The minimum concentration of ?% solids? for the recombinant hcv antigen coated microparticles of the axsym anti-hcv reagent pack is being changed from ?0. 05%? to ?0. 04%? to align with current manufacturing process.