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IVD CAPSULE Control PSP P02.00040

by Abionic SA

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 Number07649996894090 UDI-DI Date29 Sep 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  • Withdrawn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

Trade Name
IVD CAPSULE Control PSP
Generic Name
Pancreatic stone protein (PSP) IVD, control
Model / Reference
P02.00040
Primary DI / UDI-DI
07649996894090
FDA Product Code
JJX
GMDN Term
Pancreatic stone protein (PSP) IVD, control
Device Class
Class I
Regulation Number
862.1660
GUDID distribution status
In Commercial Distribution

Other devices from Abionic SA

Properties

  • Single Use
  • Prescription Use
  • Convenience Kit
  • Premarket Exempt
  • Lot / Batch Number
  • Expiration Date

Other properties (8)

  • Sterile: No
  • Implantable: No
  • Contains Latex: No
  • Over-the-Counter: No
  • Combination Product: No
  • HCT/P: No
  • Serial Number: No
  • Manufacturing Date: No