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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-HBSAG REAGENT PACK, CALIBRATORS, AND CONFIRMATORY KIT
Classification Nametest, hepatitis b (b core, be antigen, be antibody, b core igm)
Generic Namehepatitis b surface antigen assay/confirmatory kit
ApplicantORTHO-CLINICAL DIAGNOSTICS, INC.
PMA NumberP000044
Supplement NumberS002
Date Received05/29/2001
Decision Date06/18/2001
Product Code
LOM[ Registered Establishments with LOM ]
Advisory Committee Microbiology
Supplement Type30-day notice
Supplement Reason process change: manufacturing
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Change to the acceptance criteria applied to the test for human plasma used as a raw material in the formulation of assay reagent, a component of the vitros hbsag reagent pack and in the formulation of sample diluent, a component of the vitros hbasag confirmatory kit.
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