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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 may have changed. Be sure to look at the supplements to get an up-to-date view of this device.
 
DeviceVITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HBE REAGENT PACK/ANTI-HBE CALIBRATOR/ANTI HBE CONTROLS
Classification Nametest, hepatitis b (b core, be antigen, be antibody, b core igm)
Generic Nametest, hepatitis b (b core, be antigen, be antibody, b core igm)
Applicant
ORTHO-CLINICAL DIAGNOSTICS
100 indigo creek dr.
rochester, NY 14626-5101
PMA NumberP100001
Date Received01/29/2010
Decision Date07/20/2011
Product Code
LOM[ Registered Establishments with LOM ]
Docket Number 11M-0563
Notice Date 08/01/2011
Advisory Committee Microbiology
Expedited Review Granted? No
Combination Product No
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
Supplements: S001 S002 S003 S004 S005 S006 S007 S008 S009 
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