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microINR® Expert Kit KTQ0001AD

by Iline Microsystems Sl

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 Number08436540291141 UDI-DI Date22 Apr 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  • Withdrawn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
microINR® Expert Kit
Generic Name
Coagulation analyser IVD, home-use, battery-powered
Model / Reference
KTQ0001AD
Primary DI / UDI-DI
08436540291141
FDA Product Code
GJS
GMDN Term
Coagulation analyser IVD, home-use, battery-powered
Device Class
Class II
Regulation Number
864.7750
GUDID distribution status
In Commercial Distribution

Other devices from Iline Microsystems Sl

Properties

  • Prescription Use
  • Lot / Batch Number
  • Serial Number

Other properties (11)

  • Sterile: No
  • Single Use: No
  • Implantable: No
  • Contains Latex: No
  • Over-the-Counter: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Premarket Exempt: No
  • Expiration Date: No
  • Manufacturing Date: No