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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/function or indication may have changed. Be sure to look at the supplements to get an up-to-date information on device changes. The labeling included below is the version at time of approval of the original PMA or panel track supplement and may not represent the most recent labeling.
 
DeviceBIO-RAD MONOLISA ANTI-HBC EIA
Generic NameQualitative and Quantitative Hepatitis B Virus Antibody assays
Regulation Number866.3173
ApplicantBio-Rad Laboratories, Inc.
6565 185th Ave., NE
Redmond, WA 98052
PMA NumberP060031
Date Received10/30/2006
Decision Date04/27/2007
Reclassified Date10/20/2025
Product Code SEI 
Docket Number 07M-0467
Notice Date 12/04/2007
Advisory Committee Microbiology
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
RecallsCDRH 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 OrderApproval Order
SummarySummary of Safety and Effectiveness
LabelingLabeling
Supplements:  S001 S002 S003 S004 S005 S006 S007 
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