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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 HBSAG REAGENT PACK AND CALIBRATOR AND THE VITROS IMMUNODIAGNOSTIC PRODUCTS HBSAG CONFIR
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 NumberP000044
Supplement NumberS006
Date Received04/08/2005
Decision Date05/05/2005
Product Code
LOM[ Registered Establishments with LOM ]
Advisory Committee Microbiology
Supplement Typespecial (immediate track)
Supplement Reason process change - manufacturer/sterilizer/packager/supplier
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
APPROVAL FOR CHANGES IN THE MANUFACTURING PROCESS WHICH ADD AN INCOMING RAW MATERIAL TEST.
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