Skip to content

Ihc

by Slmp, LLC 260 variants

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 31 May 2026. What this means

Regulatory status

as of registry sync 31 May 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number00810170552977 UDI-DI Date14 Mar 2025ListedStatusListed GUDID: in commercial distribution

Coverage

1 jurisdiction

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  • Withdrawn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

United States — GUDID listing Listed

Specification

GUDID

Generic name
Cytokeratin IVD, antibody
Model / Ref / Catalog
(BTO) Sample Cytokeratin AE1 Acidic (AE1) Antibody (2ml), SAM-MM49-2
Primary DI / UDI-DI
00810170552977
FDA product code
NJT
GMDN term
Cytokeratin IVD, antibody
Device class
Class I
Regulation number
864.1860
GUDID distribution status
In Commercial Distribution

Related devices

Category: Cytokeratin IVD, antibody

Other devices from Slmp, LLC

See all devices from Slmp, LLC →

Properties

  • Single use
  • Premarket exempt

Other properties (13)

  • Supplied sterile: No
  • Sterilise before use: No
  • Implantable: No
  • Contains latex: No
  • Prescription use: No
  • Over-the-counter: No
  • Convenience kit: No
  • Combination product: No
  • HCT/P: No
  • Lot / batch number: No
  • Serial number: No
  • Expiration date: No
  • Manufacturing date: No