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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)
PMA NumberP060031
Date Received10/30/2006
Decision Date04/27/2007
Product Code
LOM[ Registered Establishments with LOM ]
Docket Number 07M-0467
Notice Date 12/04/2007
Advisory Committee Microbiology
Expedited Review Granted? No
Combination Product No
Information About: Labeling, Approval Order, Summary of Safety and Effectiveness
Recalls CDRH Recalls
Approval Order Statement 
Approval for the bio-rad monolisa anti-hbc eia. The device is indicated for: the monolisa anti-hbc eia is an enzyme immunoassay intended for use in the qualitative detection of total antibodies (igg/igm) to hepatitis b core antigen (anti-hbc) in human serum and plasma (potassium edta, sodium citrate, acd (acid citrate dextrose), lithium heparin and sodium heparin). Assay results may be used with other hbv serological markets for the laboratory diagnosis of hbv disease associated with hbv infection.
Approval Order Approval Order
Supplements: S001 S002 S003 S004 S005 S006 S007