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. |
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Device | VITROS IMMUNODIAGNOSTIC PRODUCTS/HBSAG REAGENT PACK,VITROS IMMUNODIAGNOSTIC PRODUCTS CONFIRMATORY KIT, AND VITROS IMMUNR |
Generic Name | Test, hepatitis b (b core, be antigen, be antibody, b core igm) |
Applicant | Ortho-Clinical Diagnostics, Inc. 100 INDIGO CREEK DR. ROCHESTER, NY 14626-5101 |
PMA Number | P000044 |
Date Received | 11/01/2000 |
Decision Date | 04/27/2001 |
Product Code |
LOM |
Docket Number | 01M-0226 |
Notice Date | 05/14/2001 |
Advisory Committee |
Microbiology |
Expedited Review Granted? | No |
Combination Product | No |
Recalls | CDRH Recalls |
Approval Order Statement APPROVAL FOR THE VITROS IMMUNODIAGNOSTIC PRODUCTS HBSAG REAGENT PACK, VITROS IMMUNODIAGNOSTIC PRODUCTS CONFIRMATORY KIT, AND VITROS IMMUNODIAGNOSTIC PRODUCTS CALIBRATOR. THE VITROS IMMUNODIAGNOSTICS HBSAG REAGENT PACK IS INDICATED FOR THE IN VITRO QUALITATIVE DETECTION OF HEPATITIS B SURFACE ANTIGEN (HBSAG) IN HUMAN SERUM AND PLASMA (HEPARIN, EDTA, AND SODIUM CITRATE) 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. IN ADDITION, THIS ASSAY MAY BE USED TO SCREEN FOR HEPATITIS B INFECTION IN PREGNANT WOMEN TO IDENTIFY NEONATES WHO ARE AT HIGH RISK OF ACQUIRING HBV DURING THE PERINATAL PERIOD. THE VITROS IMMUNODIAGNOSTIC PRODUCTS HBSAG CALIBRATOR IS INDICATED FOR USE IN THE CALIBRATION OF THE VITROS IMMUNODIAGNOSTIC SYSTEM FOR THE QUALITATIVE IN VITRO DETERMINATION OF HEPATITIS B SURFACE ANTIGEN (HBSAG) IN HUMAN SERUM OR PLASMA (HEPARIN, EDTA, AND SODIUM CITRATE) USING VITROS HBSAG REAGENT PACKS. THE VITROS HBSAG CALIBRATOR HAS BEEN VALIDATED FOR USE ONLY ON THE VITROS SYSTEM WITH THE VITROS IMMUNODIAGNOSTIC PRODUCTS HBSAG REAGENT PACK. REFER TO THE VITROS HBSAG REAGENT PACK INSTRUCTIONS FOR USE FOR FURTHER DETAILS. THE VTIROS HBSAG CONFIRMATORY KIT IS INDICATED FOR THE QUALITATIVE CONFIRMATION OF HEPATITIS B SURFACE ANTIGEN (HBSAG) IN HUMAN SERUM AND PLASMA (HEPARIN, EDTA, AND SODIUM CITRATE) SPECIMENS THAT HAVE BEEN FOUND TO BE REPEATEDLY REACTIVE USING THE VITROS IMMUNODIAGNOSTIC PRODUCTS HBSAG REAGENT PACK AND THE VITROS IMMUNODIAGNOSTIC PRODUCTS HBSAG CALIBRATOR. THE VITROS HBSAG CONFIRMATORY KIT IS FOR USE WITH THE VITROS ECI IMMUNODIAGNOSTIC SYSTEM. |
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 S030 S031 S032 S033 S034 S035 S036 S037 S038 S039 S040 |
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