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Prime Screen DSODOA-116-COT-P

by Wondfo USA Co., Ltd.

Prime Screen DSODOA-116-COT-P is a Class I device made by Wondfo USA Co., Ltd., listed in FDA GUDID since 24 Dec 2024 (UDI-DI 00816862026191), registry data as of 22 Oct 2026.

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

Source GUDID, synced 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number00816862026191 UDI-DI Date24 Dec 2024ListedStatusListed GUDID: in commercial distribution

Official records

Coverage

1 jurisdiction

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  • Withdrawn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

United States — GUDID listing Listed

Specification

GUDID

Trade name
Prime Screen
Generic name
Cotinine IVD, kit, rapid ICT, clinical
Model / reference
DSODOA-116-COT-P
Primary DI / UDI-DI
00816862026191
FDA product code
MRS
GMDN term
Cotinine IVD, kit, rapid ICT, clinical
Device class
Class I
Regulation number
862.3220
GUDID distribution status
In Commercial Distribution

Related devices

Category: Cotinine IVD, kit, rapid ICT, clinical

Similar devices

Other devices filed under FDA product code MRS (Test System, Nicotine, Cotinine, Metabolites).

Other devices from Wondfo USA Co., Ltd.

See all devices from Wondfo USA Co., Ltd. →

Properties

  • Single use
  • Premarket exempt
  • Lot / batch number
  • Expiration date
Other properties (11, all answered No)