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U.S. Department of Health and Human Services

Premarket Approval (PMA)

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Trade NameGONOCOCCAL PILI ANTIBODY TEST
Classification Namekit, identification, neisseria gonorrhoeae
Generic Namegonorrhea serology test
Regulation Number866.2660
ApplicantBIOQUEST
PMA NumberP770002
Date Received05/23/1977
Decision Date07/18/1979
Withdrawal Date 12/21/2007
Product Code
JSX[ Registered Establishments with JSX ]
Notice Date 06/13/1980
Advisory Committee Microbiology
Expedited Review Granted? No
Combination Product No
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