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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-HBC REAGENT PACK & CALIBRATOR
Classification Nametest, hepatitis b (b core, be antigen, be antibody, b core igm)
Generic Nameantibody to hepatitis b core antigen (anti-hbc) assay
ApplicantORTHO-CLINICAL DIAGNOSTICS
PMA NumberP030024
Supplement NumberS010
Date Received02/12/2009
Decision Date09/11/2009
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 the revision of the intended use to include user of the vitros 5600 integrated system and vitros 3600 immunodiagnostic system with the anti-hbc assay. The device, as modified, will be marketed under the trade name vitros immunodiagnostic products anti-hbc reagent pack and vitros immunodiagnostic products anti-hbc calibrator and is indicated for: vitros immunodiagnostic products anti-hbc reagent pack: for the in vitro qualitative detection of total antibody (lgg and igm) to hepatitis b core antigen (total anti-hbc) in human adult and pediatric serum and plasma (edta and citrate) and neonate serum using the vitros eci/eciq immunodiagnostic systems, the vitros 3600 immunodiagnostic system and the vitros 5600 integrated system. Assay 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. The presence of anti-hbc may be used as an aid in the determination of exposure to hbv infection for individuals prior to hbv vaccination. Vitros immunodiagnostic products anti-hbc 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 in vitro qualitative detection of total antibody (igg and igm) to hepatitis b virus core antigen (total anti hbc) in human adult and pediatric serum and plasma (edta and citrate) and neonate serum using vitros anti-hbc igm reagent packs. The vitros anti-hbc calibrator has been validated for use only on the vitros eci/eciq immunodiagnostic systems, the vitros 3600 immunodiagnostic system and the vitros 5600 integrated system with the vitros immunodiagnostic products anti-hbc reagent packs.
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