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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.
 
DeviceVITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HBC REAGENT PACK/CALIBRATOR
Generic NameTest, hepatitis b (b core, be antigen, be antibody, b core igm)
ApplicantORTHO-CLINICAL DIAGNOSTICS
100 INDIGO CREEK DR.
ROCHESTER, NY 14626-5101
PMA NumberP030024
Date Received06/19/2003
Decision Date03/04/2004
Product Code LOM 
Docket Number 04M-0341
Notice Date 08/04/2004
Advisory Committee Microbiology
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
APPROVAL FOR THE VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HBC REAGENT PACK AND VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HBC CALIBRATOR. THESE DEVICES ARE INDICATED FOR: 1) VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HBC REAGENT PACK IS INDICATED FOR THE IN VITRO QUALITATIVE DETECTION OF TOTAL ANTIBODY (IGG AND IGM) TO HEPATITIS B CORE ANTIGEN (TOTAL ANTI-HBC) IN HUMAN ADULT AND PEDIATRIC SERUM AND PLASMA (EDTA AND CITRATE) AND NEONATE SERUM USING THE VITROS ECI IMMUNODIAGNOSTIC SYSTEM. ASSAY RESULTS, IN CONJUNCTION WITH OTHER SEROLOGICAL AND CLINICAL INFORMATION, MAY BE USED FOR THE LABORATORY DIAGNOSIS OF INDIVIDUALS WITH ACUTE OR CHRONIC HEPATITIS B, OR RECOVERY FROM HEPATITIS B INFECTION. THE PRESENCE OF ANTI-HBC MAY BE USED AS AN AID IN THE DETERMINATION OF EXPOSURE TO HBV INFECTION FOR INDIVIDUALS PRIOR TO HBV VACCINATION. 2) VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HBC CALIBRATOR IS INDICATED FOR USE IN THE CALIBRATION OF THE VITROS ECI IMMUNODIAGNOSTIC SYSTEM WHEN USED FOR THE IN VITRO QUALITATIVE DETECTION OF TOTAL ANTIBODY (IGG AND IGM) TO HEPATITIS B CORE ANTIGEN (TOTAL ANTI-HBC) IN HUMAN ADULT AND PEDIATRIC SERUM AND PLASMA (EDTA AND CITRATE) AND NEONATE SERUM USING VITROS ANTI-HBC REAGENT PACKS.
Approval OrderApproval Order
SummarySummary of Safety and Effectiveness
LabelingLabeling
Supplements:  S001 S002 S003 S004 S005 S006 S007 S008 S009 S010 S011 
S012 S013 S014 S015 S016 S017 S018 S019 S020 S021 S022 S023 
S024 S025 S026 S027 S028 S029 
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