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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 NameABBOTT AXSYM ANTIBODY TO HCV (ANTI-HCV)
Classification Nameassay,enzyme linked immunosorbent,hepatitis c virus
Generic Nameantibody to hepatitis c virus
ApplicantABBOTT LABORATORIES
PMA NumberP970027
Supplement NumberS007
Date Received02/02/2009
Decision Date07/08/2009
Product Code
MZO[ Registered Establishments with MZO ]
Advisory Committee Microbiology
Supplement Typereal-time process
Supplement Reason labeling change - minor
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for a change in the antimicrobial formulation to the axsym anti-hcv reagent sdb2 (specimen diluent). In addition, due to the reformulation of the sdb2, the instruction to use sterile water for tubing decontamination is no longer a required procedure and can be removed from the package insert labeling.
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