Home GUDID 00895330002677 Healgen (Private Label) - 8104C
Primary DI 00895330002677
Brand Healgen (Private Label) - 8104C
Company CONFIRM BIOSCIENCES, INC.
Model CB-HE-CUP-8104
Device description Healgen (DrugConfirm) - 10 Panel CLIA Cup AMP1000/BUP10/ BZO300/COC300/mAMP1000/MDMA500/MTD300/MOP2000/OXY100/THC50
Published 2016-09-07
Public version status Update
Distribution status In Commercial Distribution
MRI safety Labeling does not contain MRI Safety Information
Single use true Product Codes# Code, Name table Code Name DKE Reagents, Test, Tetrahydrocannabinol 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
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class DKE Reagents, Test, Tetrahydrocannabinol 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
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status 00895330002677 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 00895330002677 00895330002677 895330002677 0895330002677
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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