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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 Nameassay,enzyme linked immunosorbent,hepatitis c virus
100 abbott park road
ap5n-2, dept 09vb
abbott park, IL 60064
PMA NumberP050042
Supplement NumberS002
Date Received01/11/2007
Decision Date03/05/2007
Product Code
MZO[ Registered Establishments with MZO ]
Advisory Committee Microbiology
Supplement Typereal-time process
Supplement Reason labeling change - indications/instructions/shelf life/tradename
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval to extend the expiration dating of reagents, calibrators, and controls to 14 months. The device, as modified, will be marketed under the trade name architect anti-hcv and is indicated for the qualitative detection of immunoglobulin g (igg) and immunoglobulin m (igm) antibodies to hepatitis c virus (anti-hcv) in human adult and pediatric serum and plasma (potassium edta, lithium heparin, and sodium heparin).