iScreen Urine Test DX Drug Screen Tox Cup

Basic Information

• Brand Name: iScreen Urine Test DX Drug Screen Tox Cup
• Primary DI: 06936983166256
• Version / Model: DUA-A1147C
• Catalog Number: ABTDUAW114705E
• 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: 2024-09-08
• Public Version: 1
• Public Version Date: 2024-09-16
• Public Version Status: New
• Public Device Record Key: 43b81a3a-23a9-4af5-9b58-ae491bbb335f

Device Description

25T, FDA, CLIA WAIVED (AMP500/BAR300/BUP10/BZO300/COC150/FTY1/MDMA500/MET500/MOP300/MTD300/OXY100/PCP25/TCA1000/THC50)+(OXI/CRE/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
DJG	Enzyme Immunoassay, Opiates	Clinical Toxicology	862.3650	2
NFT	Test, Amphetamine, Over The Counter	Clinical Toxicology	862.3100	2
NGM	Test, Phencyclidine (Pcp), Over The Counter	Unknown		U
NFW	Test, Cannabinoid, Over The Counter	Clinical Toxicology	862.3870	2
NGG	Test, Methamphetamine, Over The Counter	Clinical Toxicology	862.3610	2
NFV	Test, Benzodiazepine, Over The Counter	Clinical Toxicology	862.3170	2
QAW	Test, Tricyclic Antidepressants, Over The Counter	Clinical Toxicology	862.3910	2
PTG	Test, Methadone, Over The Counter	Clinical Toxicology	862.3620	2
PTH	Test, Barbiturate, Over The Counter	Clinical Toxicology	862.3150	2
NFY	Test, Cocaine And Cocaine Metabolites, Over The Counter	Clinical Toxicology	862.3250	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	06936983166256	GS1
Unit of Use	06936983166225	GS1