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Coag-Sense Prothrombin (PT) / INR Monitoring System for Patient Self-Testing 300550

by CoaguSense Inc.

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 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number00860007370809 UDI-DI Date12 May 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  • Withdrawn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
Coag-Sense Prothrombin (PT) / INR Monitoring System for Patient Self-Testing
Generic Name
Coagulation analyser IVD, home-use, battery-powered
Model / Ref / Catalog
300550
Primary DI / UDI-DI
00860007370809
GMDN Term
Coagulation analyser IVD, home-use, battery-powered
GUDID distribution status
In Commercial Distribution

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Properties

  • Prescription Use
  • Convenience Kit
  • Lot / Batch Number
  • Serial Number
  • Expiration Date
  • Manufacturing Date

Other properties (8)

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