FDA.reportPublic FDA data

DrugConfirm

Primary DI
00856464008508
Brand
DrugConfirm
Company
CONFIRM BIOSCIENCES, INC.
Model
CB-DC-1PANELOTCPACK2
Device description
1 Drug Tested Home Drug Test (THC) 2 Pack
Published
2022-10-25
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
CodeName
NFWTest, Cannabinoid, Over The Counter

Product Code Classifications#

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

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00856464008508PrimaryGS10
10856464008505Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00856464008508008564640085088564640085080856464008508
1085646400850510856464008505

GMDN Terms#

Term, Definition table
TermDefinition
Cannabinoid/cannabinoid metabolite IVD, reagentA substance or reactant intended to be used together with other IVDs to perform a specific function in an assay that is used for the qualitative and/or quantitative detection of cannabinoids and/or cannabinoid metabolites (i.e., natural, synthetic) in a clinical specimen.

Regulatory Flags#

DUNS number
806524968
Device count
2
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
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10722066015053Rapid ResponseBTNX IncNFW2026-05-15
10722066015084Rapid ResponseBTNX IncNFW2026-05-15
10648564316280SnapCheckDx Rapid Urine THC TestHangzhou Aichek Medical Technology Co., Ltd.NFW2026-05-12
16936983131633Multi-Drug Rapid Test Panel (Urine)Hangzhou AllTest Biotech Co., Ltd.NFW2026-04-16
16936983131640Multi-Drug Rapid Test Panel (Urine)Hangzhou AllTest Biotech Co., Ltd.NFW2026-04-16
16936983131657Multi-Drug Test Cup (Urine)Hangzhou AllTest Biotech Co., Ltd.NFW2026-04-16
16936983131664Multi-Drug Test Cup (Urine)Hangzhou AllTest Biotech Co., Ltd.NFW2026-04-16
16936983131671Multi-Drug Test Cup (Urine)Hangzhou AllTest Biotech Co., Ltd.NFW2026-04-16
16936983131695Multi-Drug Test Cup (Urine)Hangzhou AllTest Biotech Co., Ltd.NFW2026-04-16
16936983138632Multi-Drug 12 Drugs Rapid Test Cup Hangzhou AllTest Biotech Co., Ltd.NFW2026-04-16
16936983141120Discover Multi-Drug 12 Drugs Rapid Test Cup Hangzhou AllTest Biotech Co., Ltd.NFW2026-04-16
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16936983144688Discover Multi-Drug 10 Drugs Rapid Test Cup (Urine)Hangzhou AllTest Biotech Co., Ltd.NFW2026-04-16
16936983144770Discover Multi-Drug 9 Drugs Rapid Test Cup (Urine) Hangzhou AllTest Biotech Co., Ltd.NFW2026-04-16
16936983148846Discover Multi-Drug 12 Drugs Rapid Test Cup (Urine) Hangzhou AllTest Biotech Co., Ltd.NFW2026-04-16
16936983153819Discover Multi-Drug 13 Drugs Rapid Test Cup (Urine)Hangzhou AllTest Biotech Co., Ltd.NFW2026-04-15
16936983165379Discover Multi-Drug 5 Drugs Rapid Test Cup(Urine) Hangzhou AllTest Biotech Co., Ltd.NFW2026-04-15
16936983169599Alltest Multi-Drug Rapid Urine Test PanelHangzhou AllTest Biotech Co., Ltd.NFW2026-04-15
16936983169605Alltest Multi-Drug Rapid Urine Test PanelHangzhou AllTest Biotech Co., Ltd.NFW2026-04-15
16936983169865Discover Multi-Drug 6 Drugs Rapid Test Cup (Urine)Hangzhou AllTest Biotech Co., Ltd.NFW2026-04-15
16936983169872Discover Multi-Drug 8 Drugs Rapid Test Cup (Urine)Hangzhou AllTest Biotech Co., Ltd.NFW2026-04-15
16936983170007Alltest Multi-Drug 12 Drugs Urine Test PanelHangzhou AllTest Biotech Co., Ltd.NFW2026-04-15
16936983170014Alltest Multi-Drug 13 Drugs Urine Test PanelHangzhou AllTest Biotech Co., Ltd.NFW2026-04-15
16936983170021Alltest Multi-Drug 14 Drugs Urine Test PanelHangzhou AllTest Biotech Co., Ltd.NFW2026-04-15
16936983170038Alltest Multi-Drug 14 Drugs Urine Test PanelHangzhou AllTest Biotech Co., Ltd.NFW2026-04-15
16936983171998Alltest Multi-Drug 13 Drugs Rapid Urine Test PanelHangzhou AllTest Biotech Co., Ltd.NFW2026-04-15
16936983172025Alltest Multi-Drug 13 Drugs Rapid Urine Test PanelHangzhou AllTest Biotech Co., Ltd.NFW2026-04-15
16936983172414Alltest Multi-Drug 13 Drugs Rapid Urine Test PanelHangzhou AllTest Biotech Co., Ltd.NFW2026-04-14
16936983172421Alltest Multi-Drug 12 Drugs Rapid Urine Test PanelHangzhou AllTest Biotech Co., Ltd.NFW2026-04-14
16936983179642Alltest Multi-Drug 13 Drugs Rapid Urine Test PanelHangzhou AllTest Biotech Co., Ltd.NFW2026-04-14