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U.S. Department of Health and Human Services

Premarket Approval (PMA)

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Note: this medical device record is a supplement. The device description may have changed. Be sure to look at the original PMA to get an up-to-date view of this device.
 
Trade NameVITROS IMMUNDIAGNOSTICS PRODUCTS ANTI-HBS REAGENT PACK & CALIBRATOR
Classification Nametest, hepatitis b (b core, be antigen, be antibody, b core igm)
Generic Nameantibody to hepatitis b surface antigen (anti-hbs) assay
ApplicantORTHO-CLINICAL DIAGNOSTICS, INC.
PMA NumberP000014
Supplement NumberS019
Date Received09/04/2009
Decision Date01/11/2010
Product Code
LOM[ Registered Establishments with LOM ]
Advisory Committee Microbiology
Supplement Typenormal 180 day track
Supplement Reason change design/components/specifications - component
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for revision of the intended use to include use of the vitros 5600 integrated system and vitros 3600 immunodiagnostic system with the vitros immunodiagnostic products anti-hbs assay. The device, as modified, will be marketed under the trade names vitros immunodiagnostic products anti-hbs quantitative reagent pack, vitros immunodiagnostic products anti-hbs calibrator, and is indicated for: vitros immunodiagnostic products anti-hbs quantitative reagent pack: for the quantitative in vitro determination of total antibody to hepatitis b surface antigen (anti- hbs) in human serum using the vitros eci/eciq immunodiagnostic systems, the vitros 3600 immunodiagnostic system and the vitros 5600 integrated system. Assay results may be used as an aid in the determination of susceptibility to hepatitis b virus (hbv) infection for individuals prior to or following hbv vaccination, or where vaccination status is unknown. Assay results may be used with other hbv serological markers for the laboratory' diagnosis of hbv disease associated with hbv infection. A reactive assay result will allow a differential diagnosis in individuals displaying signs and symptoms of hepatitis, in whom etiology is unknown. Vitros immunodiagnostic products anti-hbs calibrator: for use in the calibration of the vitros eci/eciq immunodiagnostic systems, the vitros 3600 immunodiagnostic system and the vitros 5600 integrated system for the quantitative in vitro determination of total antibody to hepatitis b surface antigen (anti-hbs) in human serum using the vitros immunodiagnostic products anti-hbs quantitative reagent pack.
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