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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-HBS
Classification Nametest, hepatitis b (b core, be antigen, be antibody, b core igm)
Generic Nametotal antibodies against hepatitis b core antigen (anti-hbc) hepatitis b surface antigen (hbsag) total antibodies againa
ApplicantDIAGNOSTIC PRODUCTS CORP.
PMA NumberP010052
Supplement NumberS003
Date Received08/17/2005
Decision Date11/02/2005
Product Code
LOM[ Registered Establishments with LOM ]
Advisory Committee Microbiology
Supplement Type Special Supplement
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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