DOA Urine Cup 004

FDA UDI

Class II (US FDA UDI)

by Assure Tech. (hangzhou) Co., Ltd.

Identity

Trade Name: DOA Urine Cup 004 FDA UDI
Generic Name: Cannabinoid/cannabinoid metabolite IVD, kit, rapid ICT, clinical FDA UDI
Device Name: COC300/AMP1000/MET1000/THC50/MOR 2000 FDA UDI
Model / Reference: 1.0 FDA UDI
Description: COC300/AMP1000/MET1000/THC50/MOR 2000 FDA UDI

Identifiers

Catalog Number: MD-U65 FDA UDI
Primary DI / UDI-DI: 06952804801885 FDA UDI
510(k) Number: K170049 FDA UDI
FDA Product Code: LDJ FDA UDI
DJG FDA UDI
DJC FDA UDI
DKZ FDA UDI
DIO FDA UDI
GMDN Term: Cannabinoid/cannabinoid metabolite IVD, kit, rapid ICT, clinical FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 862.3870 FDA UDI
862.3650 FDA UDI
862.3610 FDA UDI
862.3100 FDA UDI
862.3250 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

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

FDA UDI

Category: Cannabinoid/cannabinoid metabolite IVD, kit, rapid ICT, clinical Cocaine/cocaine metabolite IVD, kit, rapid ICT, clinical Opiate/opiate metabolite IVD, kit, rapid ICT, clinical Amphetamine-specific IVD, kit, rapid ICT, clinical

DOA Urine Cup 004 by Assure Tech. (hangzhou) Co., Ltd. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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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 II	Pending data

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Manufacturer

Manufacturer: Assure Tech. (hangzhou) Co., Ltd.

Sources (1)

FDA UDI 592ef14e-2f1a-4ea3-92a7-63c22c1fb72f 35 fields · synced May 30, 2026

DOA Urine Cup 004

Identity

Identifiers

Classification

Clinical & Handling

Similar devices

Cleared under the same submission

Authorization Coverage (1 country)

Regulatory Authorizations

Manufacturer

Sources (1)