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Immco Diagnostics 1602

by Immco Diagnostics, Inc.

Immco Diagnostics 1602 is a medical device (FDA Class II; FDA product code LKJ, Antinuclear Antibody, Antigen, Control) made by Immco Diagnostics, Inc., listed in FDA GUDID since 21 Sep 2016 (UDI-DI 00845714002168), 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 Number00845714002168 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  • Withdrawn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
Multiple antinuclear antibody (ANA) IVD, reagent
Model / Ref / Catalog
1602
Primary DI / UDI-DI
00845714002168
FDA product code
LKJ
GMDN term
Multiple antinuclear antibody (ANA) IVD, reagent
Device class
Class II
Regulation number
866.5100
GUDID distribution status
In Commercial Distribution

Related devices

Category: Multiple antinuclear antibody (ANA) screening IVD, reagent

Similar devices

Other devices filed under FDA product code LKJ (Antinuclear Antibody, 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)