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STA® - Néoplastine® CI 5 00605

by Diagnostica Stago, Inc.

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

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 Number03607450006056 UDI-DI Date15 Sep 2016ListedStatusListed GUDID: not 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  • Withdrawn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
STA® - Néoplastine® CI 5
Generic Name
Prothrombin time (PT) IVD, kit, clotting
Model / Reference
00605
Primary DI / UDI-DI
03607450006056
FDA Product Code
GJS
GMDN Term
Prothrombin time (PT) IVD, kit, clotting
Device Class
Class II
Regulation Number
864.7750
GUDID distribution status
Not in Commercial Distribution

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Properties

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

Other properties (9)

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