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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.
 
DeviceARCHITECT HBSAG QUALITATIVE, QUALITATIVE CONFIRMATORY,
Generic NameTest, hepatitis b (b core, be antigen, be antibody, b core igm)
ApplicantAbbott Laboratories
100 ABBOTT PARK RD.
DEPT 09V6, BLDG. AP5-2
ABBOTT PARK, IL 60064-6088
PMA NumberP110029
Supplement NumberS024
Date Received10/14/2016
Decision Date11/10/2016
Product Code LOM 
Advisory Committee Microbiology
Supplement Type30-Day Notice
Supplement Reason Process Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
Increase the batch range and modify the pooling allowances for the bulks and concentrates for components used in the ARCHITECT HBsAg Qualitative and ARCHITECT HBsAg Qualitative Confirmatory Reagents.
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