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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 PMA supplement. A supplement may have changed the device description/function or indication from that approved in the original PMA. Be sure to look at the original PMA record for more information.
 
DeviceVITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HBC IGM REAGENT PACK AND CALIBRATORS
Classification Nametest, hepatitis b (b core, be antigen, be antibody, b core igm)
Generic Nametest, hepatitis b (b core, be antigen, be antibody, b core igm)
Applicant
Ortho-Clinical Diagnostics, Inc.
100 indigo creek dr.
rochester, NY 14626-5101
PMA NumberP030026
Supplement NumberS006
Date Received06/03/2005
Decision Date06/22/2005
Product Code
LOM[ Registered Establishments with LOM ]
Advisory Committee Microbiology
Supplement Type30-day notice
Supplement Reason process change - manufacturer/sterilizer/packager/supplier
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
ADDITION OF SERUM TO THE LIST OF RAW COMPONENTS.
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