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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.
 
Trade NameVITROS IMMUNODIAGNOSTIC PRODUCTS HBEAG REAGENT PACK/PRODUCTS HBEAG CALIBRATOR/PRODUCTS HBE CONTROLS
Classification Nametest, hepatitis b (b core, be antigen, be antibody, b core igm)
ApplicantORTHO-CLINICAL DIAGNOSTICS, INC.
PMA NumberP090028
Date Received12/17/2009
Decision Date05/11/2011
Product Code
LOM[ Registered Establishments with LOM ]
Docket Number 11M-0348
Notice Date 05/20/2011
Advisory Committee Microbiology
Clinical Trials NCT00720694
Expedited Review Granted? No
Combination Product No
Information About: Labeling, Approval Order, Summary of Safety and Effectiveness
Approval Order Statement 
Approval for the vitros immunodiagnostic products hbeag reagent pack, calibrator and controls. This device is indicated for: vitros immunodiagnostic products hbeag reagent pack for the in vitro qualitative detection of hepatitis b e antigen (hbeag) in human adult and pediatric (2 to 21 years old) serum from individuals who have symptoms of hepatitis or who may be at risk for hepatitis b virus (hbv) infection using the vitros eci/eciq immunodiagnostic system. Test 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. Vitros immunodiagnostic products hbeag calibrator for use in the calibration of the vitros eci/eciq immunodiagnostic systems for the in vitro qualitative detection of hepatitis b e antigen (hbeag) in human adult and pediatric (2 to 21 years old) serum from individuals who have symptoms of hepatitis or who may be at risk for hepatitis b virus (hbv) infection. Vitros immunodiagnostic products hbeag controls - for use in monitoring the performance of the vitros eci/eciq immunodiagnostic systems when used for the in vitro qualitative detection of hepatitis b e antigen (hbeag) in human adult and pediatric (2 to 21 years old) serum from individuals who have symptoms of hepatitis or who may be at risk for hepatitis b virus (hbv) infection when using the vitros immunodiagnostic products hbe-ag reagent pack.
Approval Order Approval Order
Supplements: S001 S002 S003 S004 S005 S006 S007 
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