iScreen™

Basic Information

• Brand Name: iScreen™
• Primary DI: 00817405022229
• Version / Model: ABTDUAW110704D
• Catalog Number: ABTDUAW110704D
• Company Name: Instant Technologies, Inc.
• Labeler DUNS: 019410187
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 25
• Record Status: Published
• Publish Date: 2022-06-16
• Public Version: 3
• Public Version Date: 2022-11-14
• Public Version Status: Update
• Public Device Record Key: d801cbd5-dbd1-467c-ad37-716d6d38806e

Device Description

iScreen™ Urine Test CLIA Waived DX Drug Screen Square Cup 10 panel with SVTs (AMP1000/BAR300/BZO300/COC300/MDMA500/MET1000/MOP300/OXY100/PCP25/THC50)+ SVT Cr, pH, S.G.

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: Yes
• 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
PTH	Test, Barbiturate, Over The Counter	Clinical Toxicology	862.3150	2
NFV	Test, Benzodiazepine, Over The Counter	Clinical Toxicology	862.3170	2
NFY	Test, Cocaine And Cocaine Metabolites, Over The Counter	Clinical Toxicology	862.3250	2
NGG	Test, Methamphetamine, Over The Counter	Clinical Toxicology	862.3610	2
NGL	Test, Opiates, Over The Counter	Clinical Toxicology	862.3650	2
LCM	Enzyme Immunoassay, Phencyclidine	Unknown		U
NFW	Test, Cannabinoid, Over The Counter	Clinical Toxicology	862.3870	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
Unit of Use	10817405022226	GS1
Primary	00817405022229	GS1
Package	30817405022220	GS1	Master Carton	4	In Commercial Distribution

Customer Contacts

• Phone: [phone]
• Email: [email protected]

Storage Conditions

• Type: Storage Environment Temperature
• Temperature Range: 4 – 30 Degrees Celsius