Multi-Drug 9 Drugs Test Cup (Urine)

Basic Information

• Brand Name: Multi-Drug 9 Drugs Test Cup (Urine)
• Primary DI: 16942598200619
• Version / Model: 1
• Catalog Number: DUA-A197C
• Company Name: Hangzhou AllTest Biotech Co., Ltd.
• Labeler DUNS: 543254717
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 25
• Record Status: Published
• Publish Date: 2026-04-13
• Public Version: 1
• Public Version Date: 2026-04-21
• Public Version Status: New
• Public Device Record Key: fc866845-ccce-4656-86e9-0c03f8b3fcdb

Device Description

25T, CLIA Waived, MOP(OPI)300/OXY100/COC150/MTD300/BZO300/AMP500/MET500/BUP10/FYL1+AD6/AD2/AD3+(CRE/SG/PH)

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): No
• Over the Counter (OTC): Yes
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
NFT	Test, Amphetamine, Over The Counter	Clinical Toxicology	862.3100	2
NGL	Test, Opiates, Over The Counter	Clinical Toxicology	862.3650	2
NFY	Test, Cocaine And Cocaine Metabolites, Over The Counter	Clinical Toxicology	862.3250	2
PTG	Test, Methadone, Over The Counter	Clinical Toxicology	862.3620	2
NFV	Test, Benzodiazepine, Over The Counter	Clinical Toxicology	862.3170	2
NGG	Test, Methamphetamine, Over The Counter	Clinical Toxicology	862.3610	2
CEN	Dye-Indicator, Ph (Urinary, Non-Quantitative)	Clinical Chemistry	862.1550	1
JMT	Diazo (Colorimetric), Nitrite (Urinary, Non-Quant)	Clinical Chemistry	862.1510	1

GMDN Terms

Code	Name	Definition	Implantable	Status
46994	Multiple drugs of abuse IVD, kit, rapid ICT, clinical	A collection of reagents and other associated materials intended to be used for the qualitative and/or (semi-)quantitative detection of multiple drugs of abuse in a clinical specimen within a short period, relative to standard laboratory testing procedures, using an immunochromatographic test (ICT) method [lateral flow test]. This is a rapid test used in the laboratory or in point-of-care analyses. It is not intended to be used for self-testing.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Unit of Use	06942598200612	GS1
Primary	16942598200619	GS1