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U.S. Department of Health and Human Services

Premarket Approval (PMA)

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Note: this medical device has supplements. The device description may have changed. Be sure to look at the supplements to get an up-to-date view of this device.
Classification Nametest, hepatitis b (b core, be antigen, be antibody, b core igm)
Generic Nametest, hepatitis b (b core, be antigen, be antibody, b core igm)
Bio-Rad Laboratories, Inc.
6565 185th ave., n.e.
redmond, WA 98052
PMA NumberP060034
Date Received11/22/2006
Decision Date05/31/2007
Product Code
LOM[ Registered Establishments with LOM ]
Docket Number 07M-0254
Notice Date 06/28/2007
Advisory Committee Microbiology
Expedited Review Granted? No
Combination Product No
Recalls CDRH Recalls
Approval Order Statement 
Approval for the bio-rad monolisa anti-hbc igm eia. The device is indicated for: the bio-rad monolisa anti-hbc igm eia is an enzyme immunoassay intended for use in the qualitative detection of igm antibodies to hepatitis b core antigen (anti-hbc igm) in human serum or plasma (potassium edta, sodium citrate, acd [acid citrate dextrose], lithium heparin and sodium heparin). Assay results may be used with other hbv serological markers for the laboratory diagnosis of hbv disease associated with hbv infection.
Approval Order Approval Order
Summary Summary of Safety and Effectiveness
Labeling Labeling
Supplements: S001 S002 S004 S005 S006 S007 S008