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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 IGM REAGENT PACK AND CALIBRATOR
Classification Nametest, hepatitis b (b core, be antigen, be antibody, b core igm)
Generic Nameanti-hbc igm assay
ApplicantORTHO-CLINICAL DIAGNOSTICS, INC.
PMA NumberP030026
Supplement NumberS016
Date Received02/20/2009
Decision Date07/15/2009
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 revision of the intended use to include use of the vitros 5600 integrated system and vitros 3600 immunodiagnostic system with the anti-hbc igm assay. The device, as modified, will be marketed under the trade name vitros immunodiagnostic products anti-hbc igm reagent pack, vitros immunodiagnostic products anti-hbc calibrator and is indicated for: vitros immunodiagnostic products anti-hbc igm reagent pack: for the in vitro qualitative detection of igm antibody to hepatitis b core antigen (anti-hbc igm) in human adult and pediatric serum and plasma (heparin, 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. Vitros immunodiagnostic products anti-hbc igm calibrator: for use in the calibration of the vitros eci/eciq immunodiagnostic systems, the vitros 3600 immunodiagnostic system and the vitros 5600 integrated system when used for the in vitro qualitative detection of igm antibody to hepatitis b virus core antigen (anti-hbc igm) in human adult and pediatric serum and plasma (edta, heparin or citrate) and neonate serum using vitros anti-hbc igm reagent packs. The vitros anti-hbc igm 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 igm reagent packs.
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