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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 IMMUNODIAGNOSTIC PRODUCTS ANTI-HBS QUANTITATIVE REAGENT PACK, VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HBS CALIBRATS
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 NumberS009
Date Received09/15/2004
Decision Date09/27/2004
Product Code
LOM[ Registered Establishments with LOM ]
Advisory Committee Microbiology
Supplement Typereal-time process
Supplement Reason labeling change - indications
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for a change from the qualitative detection of total anti-hbs in human serum to a quantitative detection of total anti-hbs in human serum. The device, as modified, will be marketed under the trade name vitros immunodiagnostic products anti-hbs quantitative reagent pack and vitros immunodiagnostic products anti-hbs calibrators. The vitros immunodiagnostic products anti-hbs quantitative reagent pack is indicated 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 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. " the vitros immunodiagnostic products anti-hbs calibrators is indicated for: "for use in the calibration of the vitros ici/eciq immunodiagnostic 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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