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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 HBSAG REAGENT PACK CALIBRATOR 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 NumberS013
Date Received05/25/2006
Decision Date07/14/2006
Product Code
LOM[ Registered Establishments with LOM ]
Advisory Committee Microbiology
Supplement Typereal-time process
Supplement Reason labeling change - performance characteristics
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for removal of a warning regarding assay performance characteristics with neonates.
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