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Amazewell DPM-COT-10B

by Guangzhou Decheng Biotechnology Co., LTD

Amazewell DPM-COT-10B is a Class I device made by Guangzhou Decheng Biotechnology Co., LTD, listed in FDA GUDID since 26 Sep 2024 (UDI-DI 00850054867025), 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 Number00850054867025 UDI-DI Date26 Sep 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  • Withdrawn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
Amazewell
Generic name
Cotinine IVD, kit, rapid ICT, clinical
Model / reference
DPM-COT-10B
Primary DI / UDI-DI
00850054867025
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 Guangzhou Decheng Biotechnology Co., Ltd.

See all devices from Guangzhou Decheng Biotechnology Co., Ltd. →

Properties

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