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Device | VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HBE REAGENT PACK/ANTI-HBE CALIBRATOR/ANTI HBE CONTROLS |
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 | P100001 |
Date Received | 01/29/2010 |
Decision Date | 07/20/2011 |
Product Code |
LOM |
Docket Number | 11M-0563 |
Notice Date | 08/01/2011 |
Advisory Committee |
Microbiology |
Expedited Review Granted? | No |
Combination Product | No |
Recalls | CDRH Recalls |
Approval Order Statement APPROVAL FOR THE VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HBE REAGENT PACK, CALIBRATOR AND CONTROLS. THIS DEVICE IS INDICATED FOR: VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HBE REAGENT PACK FOR THE IN VITRO QUALITATIVE DETECTION OF ANTIBODIES TO HEPATITIS B E ANTIGEN (ANTI-HBE) IN HUMAN ADULT AND PEDIATRIC (2 TO 21 YEARS OLD) SERUM FROM INDIVIDUALS WHO HAVE SYMPTOMS OF CHRONIC HEPATITIS AND THOSE WHO HAVE RECOVERED FROM HBV INFECTION, USING THE VITROS ECI/ECIQ IMMUNODIAGNOSTIC SYSTEMS. FURTHER ASSESSMENT OF HBV INFECTION (BIOCHEMICAL, SEROLOGICAL AND/OR NUCLEIC ACID TESTING) IS REQUIRED TO DEFINE THE SPECIFIC DISEASE STATE. VITROS ANTI-HBE TEST PERFORMANCE HAS NOT BEEN ESTABLISHED FOR THE MONITORING OF HBV DISEASE OR THERAPY. VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HBE CALIBRATOR FOR USE IN THE CALIBRATION OF THE VITROS ECI/ECIQ IMMUNODIAGNOSTIC SYSTEMS WHEN USED WITH THE VITROS ANTI-HBE TEST FOR THE IN VITRO QUALITATIVE DETECTION OF ANTIBODIES TO HEPATITIS B E ANTIGEN (ANTI-HBE). VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HBE CONTROLS FOR USE IN MONITORING THE PERFORMANCE OF THE VITROS ANTI-HBE TEST WHEN USED ON THE VITROS ECI/ECIQ IMMUNODIAGNOSTIC SYSTEMS. |
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 |