FDA.reportPublic FDA data

Healgen (Private Label) - 253

Primary DI
00856464008584
Brand
Healgen (Private Label) - 253
Company
CONFIRM BIOSCIENCES, INC.
Model
CB-HE-CUP-253
Device description
Healgen (DrugConfirm) - NO THC + PCP - 5 Panel Clicker Cup Test: AMP1000/COC300/mAMP1000/MOP2000/PCP25
Published
2024-09-27
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Single use
true

Product Codes#

Code, Name table
CodeName
NFTTest, Amphetamine, Over The Counter
NFYTest, Cocaine And Cocaine Metabolites, Over The Counter
NGGTest, Methamphetamine, Over The Counter
NGLTest, Opiates, Over The Counter
NGMTest, Phencyclidine (Pcp), Over The Counter

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
NFTTest, Amphetamine, Over The CounterClinical Toxicology2
NFYTest, Cocaine And Cocaine Metabolites, Over The CounterClinical Toxicology2
NGGTest, Methamphetamine, Over The CounterClinical Toxicology2
NGLTest, Opiates, Over The CounterClinical Toxicology2
NGMTest, Phencyclidine (Pcp), Over The CounterUnknownU

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00856464008584PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00856464008584008564640085848564640085840856464008584

GMDN Terms#

Term, Definition table
TermDefinition
Cocaine/cocaine metabolite IVD, reagentA substance or reactant intended to be used together with a parent IVD to perform a specific function in an assay that is used for the qualitative and/or quantitative detection of cocaine and/or cocaine metabolites in a clinical specimen.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
806524968
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00850041721125HealthConfirmCB-HC-Cassette-Covid Flu A/B (OTC) 2PACK2025-09-12
00850041721132HealthConfirmCB-HC-Cassette-Covid Flu A/B (OTC) 4PACK2025-09-12
00850041721118HealthConfirmCB-HC-Cassette-Covid Flu A/B (OTC)2025-09-12
20850041721129HealthConfirmCB-HC-Cassette-Covid Flu A/B (OTC) 2PACK2025-09-12
20850041721136HealthConfirmCB-HC-Cassette-Covid Flu A/B (OTC) 4PACK2025-09-12
00856464008379Healgen (Private Label) - 684CB-HE-CUP31-6842022-12-19
00856464008386Healgen (Private Label) - 6104CB-HE-CUP31-61042022-12-19
00856464008393Healgen (Private Label) - 6114CB-HE-CUP31-61142022-12-19
00895330002585Healgen (Private Label) - 1145CB-HE-11452022-12-19
00895330002967Healgen (Private Label) - 564CB-HE-5642022-12-19
00895330002547Healgen (Private Label) - 3124CB-HE-CUP-31242022-12-18
00895330002561Healgen (Private Label) - 6124CB-HE-CUP-61242022-12-18
00895330002578Healgen (Private Label) - 1125SA3CCB-HE-CUP-1125SA3C2022-12-18
00895330002592Healgen (Private Label) - 1145CB-HE-CUP-11452022-12-18
00856464008423DrugConfirmCB-DC-7PanelOTC2022-10-24
00856464008430DrugConfirmCB-DC-14PanelOTC2022-10-24
00895330002608Healgen (Private Label) - 194CB-HE-1942016-09-07
00895330002615Healgen (Private Label) - 6124CB-HE-91242016-09-07
00895330002639Healgen (Private Label) - 6125CB-HE-61252016-09-07
00895330002677Healgen (Private Label) - 8104CCB-HE-CUP-81042016-09-07

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10722066015053Rapid ResponseBTNX IncNGM2026-05-15
10722066015053Rapid ResponseBTNX IncNGG2026-05-15
10722066015053Rapid ResponseBTNX IncNGL2026-05-15
10722066015053Rapid ResponseBTNX IncNFY2026-05-15
10722066015084Rapid ResponseBTNX IncNGG2026-05-15
10722066015084Rapid ResponseBTNX IncNGL2026-05-15
10722066015084Rapid ResponseBTNX IncNGM2026-05-15
10722066015084Rapid ResponseBTNX IncNFY2026-05-15
16936983131633Multi-Drug Rapid Test Panel (Urine)Hangzhou AllTest Biotech Co., Ltd.NGL2026-04-16
16936983131633Multi-Drug Rapid Test Panel (Urine)Hangzhou AllTest Biotech Co., Ltd.NGG2026-04-16
16936983131633Multi-Drug Rapid Test Panel (Urine)Hangzhou AllTest Biotech Co., Ltd.NFT2026-04-16
16936983131633Multi-Drug Rapid Test Panel (Urine)Hangzhou AllTest Biotech Co., Ltd.NFY2026-04-16
16936983131640Multi-Drug Rapid Test Panel (Urine)Hangzhou AllTest Biotech Co., Ltd.NGL2026-04-16
16936983131640Multi-Drug Rapid Test Panel (Urine)Hangzhou AllTest Biotech Co., Ltd.NGG2026-04-16
16936983131640Multi-Drug Rapid Test Panel (Urine)Hangzhou AllTest Biotech Co., Ltd.NGM2026-04-16
16936983131640Multi-Drug Rapid Test Panel (Urine)Hangzhou AllTest Biotech Co., Ltd.NFT2026-04-16
16936983131640Multi-Drug Rapid Test Panel (Urine)Hangzhou AllTest Biotech Co., Ltd.NFY2026-04-16
16936983131657Multi-Drug Test Cup (Urine)Hangzhou AllTest Biotech Co., Ltd.NGL2026-04-16
16936983131657Multi-Drug Test Cup (Urine)Hangzhou AllTest Biotech Co., Ltd.NGM2026-04-16
16936983131657Multi-Drug Test Cup (Urine)Hangzhou AllTest Biotech Co., Ltd.NFT2026-04-16
16936983131657Multi-Drug Test Cup (Urine)Hangzhou AllTest Biotech Co., Ltd.NFY2026-04-16
16936983131657Multi-Drug Test Cup (Urine)Hangzhou AllTest Biotech Co., Ltd.NGG2026-04-16
16936983131664Multi-Drug Test Cup (Urine)Hangzhou AllTest Biotech Co., Ltd.NFT2026-04-16
16936983131664Multi-Drug Test Cup (Urine)Hangzhou AllTest Biotech Co., Ltd.NGG2026-04-16
16936983131664Multi-Drug Test Cup (Urine)Hangzhou AllTest Biotech Co., Ltd.NGM2026-04-16
16936983131664Multi-Drug Test Cup (Urine)Hangzhou AllTest Biotech Co., Ltd.NFY2026-04-16
16936983131664Multi-Drug Test Cup (Urine)Hangzhou AllTest Biotech Co., Ltd.NGL2026-04-16
16936983131671Multi-Drug Test Cup (Urine)Hangzhou AllTest Biotech Co., Ltd.NGG2026-04-16
16936983131671Multi-Drug Test Cup (Urine)Hangzhou AllTest Biotech Co., Ltd.NFY2026-04-16
16936983131671Multi-Drug Test Cup (Urine)Hangzhou AllTest Biotech Co., Ltd.NGM2026-04-16