Home GUDID 00895330002073 DrugConfirm Advanced™ 6 Panel Instant Drug Test
Primary DI 00895330002073
Brand DrugConfirm Advanced™ 6 Panel Instant Drug Test
Company CONFIRM BIOSCIENCES, INC.
Model 03-5542
Device description This kit tests for: Cocaine (COC), Marijuana (THC), Opiates (OPI), Methamphetamines (mAMP), Amphetamines (AMP), Phencyclidine (PCP)
Published 2016-09-06
Public version status Update
Distribution status In Commercial Distribution
MRI safety Labeling does not contain MRI Safety Information
OTC true
Single use true Product Codes# Code, Name table Code Name DIO Enzyme Immunoassay, Cocaine And Cocaine Metabolites DJC Thin Layer Chromatography, Methamphetamine DKE Reagents, Test, Tetrahydrocannabinol DKZ Enzyme Immunoassay, Amphetamine DOE Radioimmunoassay, Morphine (125-I), Goat Antibody Ammonium Sulfate Sep. LCM Enzyme Immunoassay, Phencyclidine
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class DIO Enzyme Immunoassay, Cocaine And Cocaine Metabolites Clinical Toxicology 2 DJC Thin Layer Chromatography, Methamphetamine Clinical Toxicology 2 DKE Reagents, Test, Tetrahydrocannabinol Clinical Toxicology 2 DKZ Enzyme Immunoassay, Amphetamine Clinical Toxicology 2 DOE Radioimmunoassay, Morphine (125-I), Goat Antibody Ammonium Sulfate Sep. Clinical Toxicology 2 LCM Enzyme Immunoassay, Phencyclidine Unknown U
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status 00895330002073 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 00895330002073 00895330002073 895330002073 0895330002073
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 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. It is not intended to be used for self-testing.
Regulatory Flags# DUNS number 806524968 Device count 1 Kit true Lot or batch true Expiration date on label true Other Devices From This Company# Primary DI, Brand, Model table Primary DI Brand Model Catalog Published 00850041721125 HealthConfirm CB-HC-Cassette-Covid Flu A/B (OTC) 2PACK 2025-09-12 00850041721132 HealthConfirm CB-HC-Cassette-Covid Flu A/B (OTC) 4PACK 2025-09-12 00850041721118 HealthConfirm CB-HC-Cassette-Covid Flu A/B (OTC) 2025-09-12 20850041721129 HealthConfirm CB-HC-Cassette-Covid Flu A/B (OTC) 2PACK 2025-09-12 20850041721136 HealthConfirm CB-HC-Cassette-Covid Flu A/B (OTC) 4PACK 2025-09-12 00856464008584 Healgen (Private Label) - 253 CB-HE-CUP-253 2024-09-27 00856464008379 Healgen (Private Label) - 684 CB-HE-CUP31-684 2022-12-19 00856464008386 Healgen (Private Label) - 6104 CB-HE-CUP31-6104 2022-12-19 00856464008393 Healgen (Private Label) - 6114 CB-HE-CUP31-6114 2022-12-19 00895330002585 Healgen (Private Label) - 1145 CB-HE-1145 2022-12-19 00895330002967 Healgen (Private Label) - 564 CB-HE-564 2022-12-19 00895330002547 Healgen (Private Label) - 3124 CB-HE-CUP-3124 2022-12-18 00895330002561 Healgen (Private Label) - 6124 CB-HE-CUP-6124 2022-12-18 00895330002578 Healgen (Private Label) - 1125SA3C CB-HE-CUP-1125SA3C 2022-12-18 00895330002592 Healgen (Private Label) - 1145 CB-HE-CUP-1145 2022-12-18 00856464008423 DrugConfirm CB-DC-7PanelOTC 2022-10-24 00856464008430 DrugConfirm CB-DC-14PanelOTC 2022-10-24 00895330002608 Healgen (Private Label) - 194 CB-HE-194 2016-09-07 00895330002615 Healgen (Private Label) - 6124 CB-HE-9124 2016-09-07 00895330002639 Healgen (Private Label) - 6125 CB-HE-6125 2016-09-07
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