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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 AND 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 NumberS007
Date Received12/14/2007
Decision Date02/12/2008
Product Code
LOM[ Registered Establishments with LOM ]
Advisory Committee Microbiology
Supplement Typereal-time process
Supplement Reason process change - other
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for the addition of a new process step to identify and dilute samples with high result signal-to-cutoff ratio (s/c) above the normal negative population and the changes involved in adding this new process. These changes are an update to the magnetic card and to the labeling of the vitros anti-hbc reagent pack to support the identification, dilution and testing of the high negative samples.
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