Discover milti-drug 8 drugs rapid test cup (urine)

Basic Information

• Brand Name: Discover milti-drug 8 drugs rapid test cup (urine)
• Primary DI: 16936983150634
• Version / Model: DUA-A187C-A3 A1617
• Catalog Number: DISP-DUD484N$
• Company Name: Hangzhou AllTest Biotech Co., Ltd.
• Labeler DUNS: 543254717
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2024-02-08
• Public Version: 1
• Public Version Date: 2024-02-16
• Public Version Status: New
• Public Device Record Key: 730b6632-607c-48e3-95c3-296f6954385b

Device Description

1T,MOP(OPI)300/OXY100/COC150/MET500/BAR300/BZO300/AMP500/BUP10+CRE/SG/PH,FDA clia waived

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
NGL	Test, Opiates, Over The Counter	Clinical Toxicology	862.3650	2
JXM	Enzyme Immunoassay, Benzodiazepine	Clinical Toxicology	862.3170	2
NFT	Test, Amphetamine, Over The Counter	Clinical Toxicology	862.3100	2
DJC	Thin Layer Chromatography, Methamphetamine	Clinical Toxicology	862.3610	2
DJG	Enzyme Immunoassay, Opiates	Clinical Toxicology	862.3650	2
NFY	Test, Cocaine And Cocaine Metabolites, Over The Counter	Clinical Toxicology	862.3250	2
PTH	Test, Barbiturate, Over The Counter	Clinical Toxicology	862.3150	2

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
Primary	16936983150634	GS1

Premarket Submissions

Submission Number	Supplement Number
K182738	000