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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.
 
DeviceMONOLISA ANTI-HBC IGM EIA
Generic NameTest, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen)
Regulation Number866.3172
ApplicantBio-Rad Laboratories, Inc.
6565 185th Ave., NE
Redmond, WA 98052
PMA NumberP060034
Supplement NumberS008
Date Received02/26/2014
Decision Date03/19/2014
Reclassified Date10/20/2025
Product Code LOM 
Advisory Committee Microbiology
Supplement Type30-Day Notice
Supplement Reason Process Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
ADDITION OF THE MILLROCK FREEZE DRYER TO THE LIST OF APPROVED EQUIPMENT FOR LYOPHILIZING THE CONJUGATE REAGENT FINAL VIALS.
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