Home GUDID 00722066004906 Rapid Response
Primary DI 00722066004906
Brand Rapid Response
Company BTNX Inc
Model D12.11.1-1VA
Device description One Step 12 Panel DOA Cup + Adulteration Test (12.11.1) - MOP300 OXY100 BZO300 MOP2000 MET500 AMP500 COC150 THC50 MDMA500 BUP10 BAR300 MTD300 + Cre/pH/Oxi
Published 2019-10-16
Public version status Update
Distribution status In Commercial Distribution
MRI safety Labeling does not contain MRI Safety Information
Rx true
OTC true
Single use true Product Codes# Code, Name table Code Name DIO Enzyme Immunoassay, Cocaine And Cocaine Metabolites DIS Enzyme Immunoassay, Barbiturate DJC Thin Layer Chromatography, Methamphetamine DJG Enzyme Immunoassay, Opiates DJR Enzyme Immunoassay, Methadone DKZ Enzyme Immunoassay, Amphetamine DNK Thin Layer Chromatography, Morphine JXM Enzyme Immunoassay, Benzodiazepine LDJ Enzyme Immunoassay, Cannabinoids NFT Test, Amphetamine, Over The Counter NFV Test, Benzodiazepine, Over The Counter NFW Test, Cannabinoid, Over The Counter NFY Test, Cocaine And Cocaine Metabolites, Over The Counter NGG Test, Methamphetamine, Over The Counter NGL Test, Opiates, Over The Counter PTG Test, Methadone, Over The Counter PTH Test, Barbiturate, Over The Counter
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 DJC Thin Layer Chromatography, Methamphetamine Clinical Toxicology 2 DJG Enzyme Immunoassay, Opiates Clinical Toxicology 2 DJR Enzyme Immunoassay, Methadone Clinical Toxicology 2 DKZ Enzyme Immunoassay, Amphetamine Clinical Toxicology 2 DNK Thin Layer Chromatography, Morphine Clinical Toxicology 2 JXM Enzyme Immunoassay, Benzodiazepine Clinical Toxicology 2 LDJ Enzyme Immunoassay, Cannabinoids Clinical Toxicology 2 NFT Test, Amphetamine, Over The Counter Clinical Toxicology 2 NFV Test, Benzodiazepine, Over The Counter Clinical Toxicology 2 NFW Test, Cannabinoid, Over The Counter Clinical Toxicology 2 NFY Test, Cocaine And Cocaine Metabolites, Over The Counter Clinical Toxicology 2 NGG Test, Methamphetamine, Over The Counter Clinical Toxicology 2 NGL Test, Opiates, Over The Counter Clinical Toxicology 2 PTG Test, Methadone, Over The Counter Clinical Toxicology 2 PTH Test, Barbiturate, Over The Counter Clinical Toxicology 2
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status 00722066004906 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 00722066004906 00722066004906 722066004906 0722066004906
GMDN Terms# Term, Definition table Term Definition Multiple drugs of abuse IVD, kit, immunochromatographic test (ICT), rapid A collection of reagents and other associated materials intended to be used for the qualitative and/or semi-quantitative detection of one or multiple drugs of abuse in a clinical specimen within a short period, relative to standard laboratory testing procedures, using an immunochromatographic test (ICT) method. This test is commonly used in the laboratory or in point-of-care analyses.
Regulatory Flags# DUNS number 251005005 Device count 1 Lot or batch true Expiration date on label true Other Devices From This Company# Other Devices Sharing Product Codes# Primary DI, Brand, Company table Primary DI Brand Company Product code Published 00817405024247 iScreen™ Instant Technologies, Inc. DIO 2026-08-01 00817405024247 iScreen™ Instant Technologies, Inc. DIS 2026-08-01 00817405024247 iScreen™ Instant Technologies, Inc. LDJ 2026-08-01 00817405024247 iScreen™ Instant Technologies, Inc. JXM 2026-08-01 00817405024247 iScreen™ Instant Technologies, Inc. DJG 2026-08-01 00810173656719 Healgen Healgen Scientific Limited Liability Company DKZ 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 DJG 2026-07-31 00810173656719 Healgen Healgen Scientific Limited Liability Company JXM 2026-07-31 00810173656719 Healgen Healgen Scientific Limited Liability Company DJR 2026-07-31 00810173656719 Healgen Healgen Scientific Limited Liability Company DIS 2026-07-31 00840050500170 OneScreen AMERICAN SCREENING, L.L.C. PTG 2022-11-11 00840050500170 OneScreen AMERICAN SCREENING, L.L.C. NFW 2022-11-11 00840050500170 OneScreen AMERICAN SCREENING, L.L.C. NGL 2022-11-11 00840050500170 OneScreen AMERICAN SCREENING, L.L.C. NGG 2022-11-11 00840050500170 OneScreen AMERICAN SCREENING, L.L.C. NFY 2022-11-11 00840050500170 OneScreen AMERICAN SCREENING, L.L.C. PTH 2022-11-11 00840050500170 OneScreen AMERICAN SCREENING, L.L.C. NFV 2022-11-11 00840050500170 OneScreen AMERICAN SCREENING, L.L.C. NFT 2022-11-11 00840050500187 OneScreen AMERICAN SCREENING, L.L.C. NFV 2022-11-11 00840050500187 OneScreen AMERICAN SCREENING, L.L.C. NGL 2022-11-11 00840050500187 OneScreen AMERICAN SCREENING, L.L.C. NGG 2022-11-11 00840050500187 OneScreen AMERICAN SCREENING, L.L.C. NFY 2022-11-11 00840050500187 OneScreen AMERICAN SCREENING, L.L.C. NFW 2022-11-11 00840050500187 OneScreen AMERICAN SCREENING, L.L.C. PTG 2022-11-11 00840050500187 OneScreen AMERICAN SCREENING, L.L.C. PTH 2022-11-11 00840050500187 OneScreen AMERICAN SCREENING, L.L.C. NFT 2022-11-11 00840050500194 OneScreen AMERICAN SCREENING, L.L.C. PTH 2022-11-11 00840050500194 OneScreen AMERICAN SCREENING, L.L.C. NGL 2022-11-11