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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-HBS REAGENT PACK/ANTI-HBS CALIBRATORS
Generic NameTest, hepatitis b (b core, be antigen, be antibody, b core igm)
ApplicantOrtho-Clinical Diagnostics, Inc.
100 INDIGO CREEK DR.
ROCHESTER, NY 14626-5101
PMA NumberP000014
Date Received03/02/2000
Decision Date09/29/2000
Product Code LOM 
Docket Number 00M-1658
Notice Date 12/12/2000
Advisory Committee Microbiology
Expedited Review Granted? No
Combination ProductNo
RecallsCDRH Recalls
Approval Order Statement  
APPROVAL FOR THE VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HBS REAGENT PACK AND CALIBRATORS. THE DEVICE IS INDICATED FOR: THE QUALITATIVE IN VITRO DETERMINATION OF TOTAL ANTIBODY TO HEPATITIS B SURFACE ANTIGEN (ANTI-HBS) IN HUMAN SERUM USING THE VITROS ECI IMMUNODIAGNOSTIC SYSTEM. ASSAY RESULTS MAY BE USED AS AN AID IN THE DETERMINATINO OF SUSCEPTIBILITY TO HEPATITIS B VIRUS (HBV) INFECTION FOR INDIVIDUALS PRIOR TO OR FOLLOWING HBV VACCINATION, OR WHERE VACCINATION STATUS IS UNKNOWN. ASSAY RESULTS MAY BE USED WITH OTHER HBV SEROLOGICAL MARKERS FOR THE LABORATORY DIAGNOSIS OF HBV DISEASE ASSOCIATED WITH HBV INFECTION. A REACTIVE ASSAY RESULT WILL ALLOW A DIFFERENTIAL DIAGNOSIS IN INDIVIDUALS DISPLAYING SIGNS AND SYMPTOMS OF HEPATITIS IN WHOM ETIOLOGY IS UNKNOWN.
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 S030 S031 S032 S033 S034 S035 
S036 
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