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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.
 
Trade NameBIO RAD MONOLISA ANTI-HBC IGM EIA
Classification Nametest, hepatitis b (b core, be antigen, be antibody, b core igm)
ApplicantBIO-RAD LABORATORIES, INC.
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
Information About: Labeling, Approval Order, Summary of Safety and Effectiveness
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
Supplements: S001 S002 S004 S005 S006 
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