Amazewell

FDA UDI

Class I (US FDA UDI)

by Guangzhou Decheng Biotechnology Co., LTD

Identity

Trade Name: Amazewell FDA UDI
Generic Name: Cotinine IVD, kit, rapid ICT, clinical FDA UDI
Device Name: Amazewell™ D-Pen™ Mini COT Oral Fluid Test, 10T/Box FDA UDI
Model / Reference: DPM-COT-10B FDA UDI
Description: Amazewell™ D-Pen™ Mini COT Oral Fluid Test, 10T/Box FDA UDI

Identifiers

Primary DI / UDI-DI: 00850054867025 FDA UDI
FDA Product Code: MRS FDA UDI
GMDN Term: Cotinine IVD, kit, rapid ICT, clinical FDA UDI

Classification

Device Class: Class I FDA UDI
Regulation Number: 862.3220 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

FDA UDI

Single Use

Yes

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

Yes

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

FDA UDI

Category: Cotinine IVD, kit, rapid ICT, clinical

Amazewell by Guangzhou Decheng Biotechnology Co., LTD — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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FirstCheck Cotinine Oral Fluid Test — Hangzhou AllTest Biotech Co., Ltd. · Class I

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Source	Region	Type	Cert / Approval No.	Class	Status
FDA UDI	United States	FDA UDI	Registered in GUDID	Class I	Pending data

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Manufacturer

Manufacturer: Guangzhou Decheng Biotechnology Co., LTD

Sources (1)

FDA UDI f8c6e6f2-c6e9-4347-9166-e913ba6ce1a5 33 fields · synced May 30, 2026