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Immco Diagnostics 5159A

by Immco Diagnostics, Inc.

Immco Diagnostics 5159A is a Class II device made by Immco Diagnostics, Inc., listed in FDA GUDID since 21 Sep 2016 (UDI-DI 00845714001857), not in commercial distribution (GUDID) as of 23 Oct 2026.

Listed FDA GUDID listing, not in commercial distribution

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 Number00845714001857 UDI-DI Date21 Sep 2016ListedStatusListed GUDID: not 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  • Withdrawn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
Immco Diagnostics
Generic name
Gliadin antibody IVD, kit, enzyme immunoassay (EIA)
Model / Ref / Catalog
5159A
Primary DI / UDI-DI
00845714001857
FDA product code
MST
GMDN term
Gliadin antibody IVD, kit, enzyme immunoassay (EIA)
Device class
Class II
Regulation number
866.5750
GUDID distribution status
Not in Commercial Distribution

Similar devices

Other devices filed under FDA product code MST (Antibodies, Gliadin).

Other devices from Immco Diagnostics, Inc.

See all devices from Immco Diagnostics, Inc. →

Properties

  • Prescription use
  • Convenience kit
  • Lot / batch number
  • Expiration date
  • Manufacturing date
Other properties (10, all answered No)