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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 NumberS003
Date Received03/22/2001
Decision Date04/19/2001
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 type of dispenser used to dispense the coating solution and wash buffers during the manufacturing of the coated microwells, a component of the product.
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