FDA.reportPublic FDA data

Healgen (Private Label) - 564

Primary DI
00895330002967
Brand
Healgen (Private Label) - 564
Company
CONFIRM BIOSCIENCES, INC.
Model
CB-HE-564
Device description
Healgen (DrugConfirm) - 6 Panel Dip Test: BZO300/COC300/mAMP1000/MOP2000/OXY100/THC50
Published
2022-12-19
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
OTC
true
Single use
true

Product Codes#

Code, Name table
CodeName
NFVTest, Benzodiazepine, Over The Counter
NFWTest, Cannabinoid, Over The Counter
NFYTest, Cocaine And Cocaine Metabolites, Over The Counter
NGGTest, Methamphetamine, Over The Counter
NGLTest, Opiates, Over The Counter

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
NFVTest, Benzodiazepine, Over The CounterClinical Toxicology2
NFWTest, Cannabinoid, 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

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00895330002967PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00895330002967008953300029678953300029670895330002967

GMDN Terms#

Term, Definition table
TermDefinition
Benzodiazepine group 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 one or multiple benzodiazepines in a clinical specimen.

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 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
00856464008584Healgen (Private Label) - 253CB-HE-CUP-2532024-09-27
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
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
00311917077932WalgreensWALGREEN CO.NGG2026-10-14
00311917077932WalgreensWALGREEN CO.NGL2026-10-14
00311917077932WalgreensWALGREEN CO.NFY2026-10-14
00311917077932WalgreensWALGREEN CO.NFW2026-10-14
06937339211507BioSieveVivachek Biotech (Hangzhou) Co., Ltd.NFW2026-10-14
06937339211507BioSieveVivachek Biotech (Hangzhou) Co., Ltd.NGG2026-10-14
06937339211507BioSieveVivachek Biotech (Hangzhou) Co., Ltd.NFV2026-10-14
06937339211507BioSieveVivachek Biotech (Hangzhou) Co., Ltd.NFY2026-10-14
06937339211507BioSieveVivachek Biotech (Hangzhou) Co., Ltd.NGL2026-10-14
06937339211538BioSieveVivachek Biotech (Hangzhou) Co., Ltd.NFW2026-10-14
06937339211538BioSieveVivachek Biotech (Hangzhou) Co., Ltd.NGG2026-10-14
06937339211538BioSieveVivachek Biotech (Hangzhou) Co., Ltd.NFV2026-10-14
06937339211538BioSieveVivachek Biotech (Hangzhou) Co., Ltd.NFY2026-10-14
06937339211538BioSieveVivachek Biotech (Hangzhou) Co., Ltd.NGL2026-10-14
06974541566049BioTekeBioteke Corporation (Wuxi) Co., Ltd.NFY2026-10-13
06974541566049BioTekeBioteke Corporation (Wuxi) Co., Ltd.NGL2026-10-13
06974541566049BioTekeBioteke Corporation (Wuxi) Co., Ltd.NFV2026-10-13
06974541566049BioTekeBioteke Corporation (Wuxi) Co., Ltd.NGG2026-10-13
06942598249383One Step® Buprenorphine (BUP10) Home Rapid Test DipstickHangzhou AllTest Biotech Co., Ltd.NGL2026-10-12
06942598249390One Step® Benzodiazepines (BZO300) Home Rapid Test DipstickHangzhou AllTest Biotech Co., Ltd.NFV2026-10-12
06942598249406One Step® Methamphetamine (MET500) Home Rapid Test DipstickHangzhou AllTest Biotech Co., Ltd.NGG2026-10-12
06942598249420One Step® Morphine (MOP/OPI2000) Home Rapid Test DipstickHangzhou AllTest Biotech Co., Ltd.NGL2026-10-12
10722066005511Rapid ResponseBTNX IncNGL2026-10-09
10722066005511Rapid ResponseBTNX IncNGG2026-10-09
10722066005511Rapid ResponseBTNX IncNFY2026-10-09
10722066005511Rapid ResponseBTNX IncNFW2026-10-09
10722066005511Rapid ResponseBTNX IncNFV2026-10-09
06936983113939Alltest MDMA500 Rapid Test Panel (Urine)Hangzhou AllTest Biotech Co., Ltd.NGG2026-04-21
06936983113946Alltest MET500 Rapid Test Panel (Urine)Hangzhou AllTest Biotech Co., Ltd.NGG2026-04-21
06936983113953Alltest MOP300 Rapid Test Panel (Urine)Hangzhou AllTest Biotech Co., Ltd.NGL2026-04-21