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Histofluor® Primate Esophagus Autoantibody Fluorescent Test System 12160-01R

by Immuno Concepts Inc

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

Registry data, not yet checked by deviCERTS. Source GUDID, synced 23 Oct 2026. What this means

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing NumberM7491216001R1 UDI-DI Date5 Feb 2026ListedStatusListed GUDID: in commercial distribution

Coverage

1 jurisdiction

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  • Withdrawn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

United States — GUDID listing Listed

Specification

GUDID

Trade Name
Histofluor® Primate Esophagus Autoantibody Fluorescent Test System
Generic Name
Endomysium antibody (EMA) IVD, kit, fluorescent immunoassay
Model / Ref / Catalog
12160-01R
Primary DI / UDI-DI
M7491216001R1
GMDN Term
Endomysium antibody (EMA) IVD, kit, fluorescent immunoassay
GUDID distribution status
In Commercial Distribution

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Properties

  • Single Use
  • Convenience Kit
  • Lot / Batch Number
  • Expiration Date
  • Manufacturing Date

Other properties (9)

  • Sterile: No
  • Implantable: No
  • Contains Latex: No
  • Prescription Use: No
  • Over-the-Counter: No
  • Combination Product: No
  • HCT/P: No
  • Premarket Exempt: No
  • Serial Number: No