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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 NameIMMULITE/IMMULITE 1000 AND IMMULITE 2000 ANTI-HBC ASSAYS
Classification Nametest, hepatitis b (b core, be antigen, be antibody, b core igm)
Generic Nametotal antibodies against hepatitis b core antigen (ant0hbc igm)
ApplicantDIAGNOSTIC PRODUCTS CORP.
PMA NumberP010051
Supplement NumberS004
Date Received12/22/2005
Decision Date06/16/2006
Product Code
LOM[ Registered Establishments with LOM ]
Advisory Committee Microbiology
Supplement Typereal-time process
Supplement Reason labeling change - performance characteristics
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for revision of the analytical sensitivity claim for the immulite/ immulite 1000 and immulite 2000 anti-hbc assays.
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