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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-HBS REAGENT PACK AND CALIBRATORS
Classification Nametest, hepatitis b (b core, be antigen, be antibody, b core igm)
Generic Nameantibody to hepatitis b surface antigen (anti-hbs) assay
ApplicantORTHO-CLINICAL DIAGNOSTICS, INC.
PMA NumberP000014
Supplement NumberS007
Date Received05/05/2004
Decision Date05/14/2004
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 
Replacement of key equipment used in performing the coated well test procedure and the acceptance criteria associated with its use. In addition, the coated well sampling plan, randomization methods for sampling, and test error correction methods have been improved to further ensure batch quality and reduce production waste. The coated well test procedure is used to verify an acceptable level of well-to-well precision and outlier-level incidence in the coated wells manufactured for the vitros anti-hbs assay.
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