Home GUDID 00817405024247 iScreen™
Primary DI 00817405024247
Brand iScreen™
Company Instant Technologies, Inc.
Model 4591320131
Catalog number DCB-1115-011
Device description CLIA Waived multi-CLIN™ Drug Screen Test Device
Published 2026-08-01
Public version status New
Distribution status In Commercial Distribution
MRI safety Labeling does not contain MRI Safety Information
Rx false
OTC false
Sterile false
Single use true Product Codes# Code, Name table Code Name DIO Enzyme Immunoassay, Cocaine And Cocaine Metabolites DIS Enzyme Immunoassay, Barbiturate DJG Enzyme Immunoassay, Opiates JXM Enzyme Immunoassay, Benzodiazepine JXN Enzyme Immunoassay, Propoxyphene LAF Gas Chromatography, Methamphetamine LCM Enzyme Immunoassay, Phencyclidine LDJ Enzyme Immunoassay, Cannabinoids LFG Radioimmunoassay, Tricyclic Antidepressant Drugs
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class DIO Enzyme Immunoassay, Cocaine And Cocaine Metabolites Clinical Toxicology 2 DIS Enzyme Immunoassay, Barbiturate Clinical Toxicology 2 DJG Enzyme Immunoassay, Opiates Clinical Toxicology 2 JXM Enzyme Immunoassay, Benzodiazepine Clinical Toxicology 2 JXN Enzyme Immunoassay, Propoxyphene Clinical Toxicology 2 LAF Gas Chromatography, Methamphetamine Clinical Toxicology 2 LCM Enzyme Immunoassay, Phencyclidine Unknown U LDJ Enzyme Immunoassay, Cannabinoids Clinical Toxicology 2 LFG Radioimmunoassay, Tricyclic Antidepressant Drugs Clinical Toxicology 2
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status 30817405024248 Package GS1 4 In Commercial Distribution 10815845020376 Previous GS1 0 00817405024247 Primary GS1 0
Alternate GTIN / UPC / EAN Codes Source identifier, GTIN-14 normalized, UPC-A table Source identifier GTIN-14 normalized UPC-A EAN-13 30817405024248 30817405024248 10815845020376 10815845020376 00817405024247 00817405024247 817405024247 0817405024247
GMDN Terms# Term, Definition table Term Definition 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.
Storage And Handling# Type, Low, High table Type Low High Condition Storage Environment Temperature 0 0
Regulatory Flags# DUNS number 019410187 Device count 1 DM exempt false Premarket exempt false HCT/P false Kit false Combination product false Lot or batch true Serial number false Manufacturing date on label false Expiration date on label true Donation ID number false Contains natural rubber latex false No natural rubber latex false Sterilization required before use false Other Devices From This Company# Other Devices Sharing Product Codes# Primary DI, Brand, Company table Primary DI Brand Company Product code Published B2986080760 DrugCheck Express Diagnostic Int'l, Inc. LCM 2026-09-24 B2986080760 DrugCheck Express Diagnostic Int'l, Inc. DJG 2026-09-24 B2986080760 DrugCheck Express Diagnostic Int'l, Inc. LAF 2026-09-24 B2986080760 DrugCheck Express Diagnostic Int'l, Inc. DIO 2026-09-24 B2986080760 DrugCheck Express Diagnostic Int'l, Inc. LDJ 2026-09-24 00810173656719 Healgen Healgen Scientific Limited Liability Company JXN 2026-07-31 00810173656719 Healgen Healgen Scientific Limited Liability Company LDJ 2026-07-31 00810173656719 Healgen Healgen Scientific Limited Liability Company DIO 2026-07-31 00810173656719 Healgen Healgen Scientific Limited Liability Company LAF 2026-07-31 00810173656719 Healgen Healgen Scientific Limited Liability Company DJG 2026-07-31 00810173656719 Healgen Healgen Scientific Limited Liability Company JXM 2026-07-31 00810173656719 Healgen Healgen Scientific Limited Liability Company LFG 2026-07-31 00810173656719 Healgen Healgen Scientific Limited Liability Company LCM 2026-07-31 00810173656719 Healgen Healgen Scientific Limited Liability Company DIS 2026-07-31 B07609700 LZI Fentanyl III Enzyme Immunoassay LIN-ZHI INTERNATIONAL, INC. DJG 2026-07-17 B07609710 LZI Fentanyl III Enzyme Immunoassay LIN-ZHI INTERNATIONAL, INC. DJG 2026-07-17 00841824104167 ECOII W.H.P.M. INC. LCM 2026-07-07 00841824104167 ECOII W.H.P.M. INC. LDJ 2026-07-07 00841824104167 ECOII W.H.P.M. INC. JXM 2026-07-07 00841824104167 ECOII W.H.P.M. INC. DIO 2026-07-07 00841824104167 ECOII W.H.P.M. INC. LAF 2026-07-07 00841824104167 ECOII W.H.P.M. INC. DIS 2026-07-07 00841824104167 ECOII W.H.P.M. INC. DJG 2026-07-07 00810174471229 Prime Screen® WONDFO USA CO., LTD. LCM 2026-06-26 10850013035431 Identify Health Drug Screen Test Cup MEDICAL DISTRIBUTION GROUP INC DJG 2026-06-25 10850013035431 Identify Health Drug Screen Test Cup MEDICAL DISTRIBUTION GROUP INC DIO 2026-06-25 10850013035448 Identify Health Drug Screen Test Cup MEDICAL DISTRIBUTION GROUP INC DIO 2026-06-25 10850013035448 Identify Health Drug Screen Test Cup MEDICAL DISTRIBUTION GROUP INC DJG 2026-06-25 00810173656726 Healgen Healgen Scientific Limited Liability Company LDJ 2026-06-03 00810173656726 Healgen Healgen Scientific Limited Liability Company JXN 2026-06-03