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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 Nametest, hepatitis b (b core, be antigen, be antibody, b core igm)
PMA NumberP060034
Supplement NumberS004
Date Received09/25/2009
Decision Date08/02/2010
Product Code
LOM[ Registered Establishments with LOM ]
Advisory Committee Microbiology
Supplement Typenormal 180 day track
Supplement Reason change design/components/specifications - component
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for expanding the intended use to include use with the evolis automated microplate system. The device, as modified, will be marketed under the trade name monolisa anti-hbc igm eia and is indicated 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. The monolisa anti-hbc igm is intended for manual use and with the bio-rad evolis automated microplate system in the detection of igm antibodies to hepatitis b virus.