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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 ASSAY AND HBSAG CONFIRMATORY KIT
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 NumberS028
Date Received10/05/2011
Decision Date11/10/2011
Product Code
LOM[ Registered Establishments with LOM ]
Advisory Committee Microbiology
Supplement Typereal-time process
Supplement Reason labeling change - indications/instructions/shelf life/tradename
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
APPROVAL FOR THE CHANGE IN ON-INSTRUMENT STORAGE OF PATIENT SAMPLES FROM 2 HOURS TO 3 HOURS.
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