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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 PMA supplement. A supplement may have changed the device description/function or indication from that approved in the original PMA. Be sure to look at the original PMA record for more information.
 
DeviceVITROS IMMUNDIAGNOSTICS PRODUCTS ANTI-HBS REAGENT PACK & CALIBRATOR
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
Supplement NumberS019
Date Received09/04/2009
Decision Date01/11/2010
Product Code LOM 
Advisory Committee Microbiology
Supplement TypeNormal 180 Day Track
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
APPROVAL FOR REVISION OF THE INTENDED USE TO INCLUDE USE OF THE VITROS 5600INTEGRATED SYSTEM AND VITROS 3600 IMMUNODIAGNOSTIC SYSTEM WITH THE VITROSIMMUNODIAGNOSTIC PRODUCTS ANTI-HBS ASSAY. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDERTHE TRADE NAMES VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HBS QUANTITATIVE REAGENT PACK,VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HBS CALIBRATOR, AND IS INDICATED FOR:VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HBS QUANTITATIVE REAGENT PACK:FOR THE QUANTITATIVE IN VITRO DETERMINATION OF TOTAL ANTIBODY TO HEPATITIS B SURFACE ANTIGEN (ANTI-HBS) IN HUMAN SERUM USING THE VITROS ECI/ECIQ IMMUNODIAGNOSTIC SYSTEMS, THE VITROS 3600 IMMUNODIAGNOSTIC SYSTEM AND THE VITROS 5600 INTEGRATED SYSTEM.ASSAY RESULTS MAY BE USED AS AN AID IN THE DETERMINATION OF SUSCEPTIBILITY TO HEPATITIS B VIRUS(HBV) INFECTION FOR INDIVIDUALS PRIOR TO OR FOLLOWING HBV VACCINATION, OR WHERE VACCINATIONSTATUS IS UNKNOWN. ASSAY RESULTS MAY BE USED WITH OTHER HBV SEROLOGICAL MARKERS FOR THELABORATORY' 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 WHOMETIOLOGY IS UNKNOWN.VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HBS CALIBRATOR:FOR USE IN THE CALIBRATION OF THE VITROS ECI/ECIQ IMMUNODIAGNOSTIC SYSTEMS, THE VITROS 3600 IMMUNODIAGNOSTIC SYSTEM AND THE VITROS 5600 INTEGRATED SYSTEM FOR THE QUANTITATIVE IN VITRO DETERMINATION OF TOTAL ANTIBODY TO HEPATITIS B SURFACE ANTIGEN (ANTI-HBS) IN HUMAN SERUMUSING THE VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HBS QUANTITATIVE REAGENT PACK.
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