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Gonococcal Pili Antibody Test Kit

by Bioquest

PMA P770002

Withdrawn United States

Was authorized under PMA, withdrawn

Ended

Withdrawn 18 Jul 1979

PMA

FDA recalls

None found

in data synced 6 Oct 2026

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA PMA, synced 6 Oct 2026. What this means

Regulatory status

as of registry sync 6 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA PMAAPWD Approval withdrawn NumberP770002 Date18 Jul 1979Approval withdrawnStatusWithdrawn

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 6 Oct 2026.

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA PMA Withdrawn

Specification

PMA

Full name
Gonococcal Pili Antibody Test
Generic Name
KIT, IDENTIFICATION, NEISSERIA GONORRHOEAE
PMA Number
FDA Product Code
JSX
Device Class
Class I
Regulation
21 CFR Part 866.2660
Advisory Committee
Microbiology
FDA Decision
APWD Approval withdrawn

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