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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.
 
DeviceAutoDELFIA hAFP Test System
Generic NameKIT, TEST, ALPHA-FETOPROTEIN FOR NEURAL TUBE DEFECTS
ApplicantRevvity, Inc.
77 4th St.
Waltham, MA 02451
PMA NumberP970037
Supplement NumberS012
Date Received07/15/2021
Decision Date08/11/2021
Product Code LOK 
Advisory Committee Immunology
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  
Adding the WAVE25 system and the Cogent M1 TFF system to the in vitro manufacturing of antibodies.
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