Skip to content

Immco Diagnostics 1115

by Immco Diagnostics, Inc.

Immco Diagnostics 1115 is a Class II device made by Immco Diagnostics, Inc., listed in FDA GUDID since 21 Sep 2016 (UDI-DI 00845714001185), 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 Number00845714001185 UDI-DI Date21 Sep 2016ListedStatusListed 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  • Withdrawn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
Immco Diagnostics
Generic name
Endomysium antibody (EMA) IVD, kit, fluorescent immunoassay
Model / Ref / Catalog
1115
Primary DI / UDI-DI
00845714001185
FDA product code
DBL
GMDN term
Endomysium antibody (EMA) IVD, kit, fluorescent immunoassay
Device class
Class II
Regulation number
866.5660
GUDID distribution status
In Commercial Distribution

Related devices

Category: Endomysium antibody (EMA) IVD, kit, fluorescent immunoassay

Similar devices in this category

Other devices filed under Endomysium antibody (EMA) IVD, kit, fluorescent immunoassay.

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)