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Sure-Vue T3018-5555

by Fisher Scientific Company L.L.C.

Sure-Vue T3018-5555 (23038012) is a Class II device made by Fisher Scientific Company L.L.C., listed in FDA GUDID since 27 Jun 2017 (UDI-DI 10613647000882), registry data as of 23 Oct 2026.

Listed FDA GUDID listing, no authorization on record

Valid until

Not applicable

Database listing, no authorization

FDA recalls

Not checked

No FDA submission to match recalls against

Documents

None

No authorization documents

Trust

Unverified

Source GUDID, synced 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number10613647000882 UDI-DI Date27 Jun 2017ListedStatusListed GUDID: in commercial distribution

Official records

Coverage

1 jurisdiction

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  • Withdrawn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

United States — GUDID listing Listed

Specification

GUDID

Trade name
Sure-Vue
Generic name
Treponema pallidum reagin antibody IVD, kit, agglutination
Model / Ref / Catalog
T3018-5555, 23038012
Primary DI / UDI-DI
10613647000882
FDA product code
GMP
GMDN term
Treponema pallidum reagin antibody IVD, kit, agglutination
Device class
Class II
Regulation number
866.3820
GUDID distribution status
In Commercial Distribution

Related devices

Category: Treponema pallidum reagin antibody IVD, kit, agglutination

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Other devices filed under Treponema pallidum reagin antibody IVD, kit, agglutination.

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Properties

  • Prescription use
  • Convenience kit
  • Lot / batch number
  • Expiration date
Other properties (11, all answered No)