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U.S. Department of Health and Human Services

Premarket Approval (PMA)

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Trade NameGONODECTEN
Classification Nametest reagents, neisseria gonorrhoeae biochemical
Generic Nameneisseria gonorrhoeae biochemical reagent test
Regulation Number866.2660
ApplicantMEDISERVE INTERNATIONAL, INC.
PMA NumberP770010
Supplement NumberS001
Date Received06/10/1980
Decision Date06/10/1980
Product Code
LTS[ Registered Establishments with LTS ]
Advisory Committee Microbiology
Expedited Review Granted? No
Combination Product No
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