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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/CALIBRATORS
Classification Nametest, hepatitis b (b core, be antigen, be antibody, b core igm)
ApplicantORTHO-CLINICAL DIAGNOSTICS, INC.
PMA NumberP000014
Supplement NumberS002
Date Received03/12/2001
Decision Date08/29/2001
Product Code
LOM[ Registered Establishments with LOM ]
Advisory Committee Microbiology
Supplement Type135 review track for 30-day notice
Supplement Reason process change - other
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval to change the test release limits applied to the output of that model for the vitros anti-hbs assay.
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