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Immco Diagnostics, Inc. 5163S

by Immco Diagnostics, Inc.

Immco Diagnostics, Inc. 5163S is a Class II device made by Immco Diagnostics, Inc., listed in FDA GUDID since 7 Sep 2017 (UDI-DI 00845714002526), 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 Number00845714002526 UDI-DI Date7 Sep 2017ListedStatusListed 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  • Withdrawn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, Inc.
Generic name
Mitochondrial antibody M2 (anti-Mi2) IVD, kit, enzyme immunoassay (EIA)
Model / Ref / Catalog
5163S
Primary DI / UDI-DI
00845714002526
FDA product code
DBM
GMDN term
Mitochondrial antibody M2 (anti-Mi2) IVD, kit, enzyme immunoassay (EIA)
Device class
Class II
Regulation number
866.5090
GUDID distribution status
Not in Commercial Distribution

Similar devices

Other devices filed under FDA product code DBM (Antimitochondrial Antibody, Indirect Immunofluorescent, Antigen, Control).

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)