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Device | VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HBC REAGENT PACK/CALIBRATOR |
Generic Name | Test, hepatitis b (b core, be antigen, be antibody, b core igm) |
Applicant | ORTHO-CLINICAL DIAGNOSTICS 100 INDIGO CREEK DR. ROCHESTER, NY 14626-5101 |
PMA Number | P030024 |
Date Received | 06/19/2003 |
Decision Date | 03/04/2004 |
Product Code |
LOM |
Docket Number | 04M-0341 |
Notice Date | 08/04/2004 |
Advisory Committee |
Microbiology |
Expedited Review Granted? | No |
Combination Product | No |
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 Order | Approval Order |
Summary | Summary of Safety and Effectiveness |
Labeling | Labeling
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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 |