FDA.reportPublic FDA data

DrugConfirm

Primary DI
00856464008423
Brand
DrugConfirm
Company
CONFIRM BIOSCIENCES, INC.
Model
CB-DC-7PanelOTC
Device description
7 Drugs Tested Home Drug Test
Published
2022-10-24
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
NFTTest, Amphetamine, 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
NGMTest, Phencyclidine (Pcp), Over The Counter

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
NFTTest, Amphetamine, 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
NGMTest, Phencyclidine (Pcp), Over The CounterUnknownU

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00856464008423PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00856464008423008564640084238564640084230856464008423

GMDN Terms#

Term, Definition table
TermDefinition
Amphetamine/methamphetamine group IVD, kit, rapid ICT, clinicalA collection of reagents and other associated materials intended to be used for the qualitative and/or (semi-)quantitative detection of the amphetamine and/or methamphetamine group(s) [e.g., 3,4-methylenedioxymethamphetamine (MDMA), also known as ecstasy] in a clinical specimen within a short period, relative to standard laboratory testing procedures, using an immunochromatographic test (ICT) method [lateral flow test]. This is a rapid test used in the laboratory or in point-of-care analyses. It is not intended to be used for self-testing.

Sterilization Methods#

Method table
Method

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
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
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 IncNFW2026-05-15
10722066015053Rapid ResponseBTNX IncNGM2026-05-15
10722066015053Rapid ResponseBTNX IncNGL2026-05-15
10722066015053Rapid ResponseBTNX IncNFY2026-05-15
10722066015053Rapid ResponseBTNX IncNGG2026-05-15
10722066015084Rapid ResponseBTNX IncNFW2026-05-15
10722066015084Rapid ResponseBTNX IncNFY2026-05-15
10722066015084Rapid ResponseBTNX IncNGM2026-05-15
10722066015084Rapid ResponseBTNX IncNGL2026-05-15
10722066015084Rapid ResponseBTNX IncNGG2026-05-15
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
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.NFT2026-04-16
16936983131633Multi-Drug Rapid Test Panel (Urine)Hangzhou AllTest Biotech Co., Ltd.NFY2026-04-16
16936983131633Multi-Drug Rapid Test Panel (Urine)Hangzhou AllTest Biotech Co., Ltd.NGG2026-04-16
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.NGL2026-04-16
16936983131640Multi-Drug Rapid Test Panel (Urine)Hangzhou AllTest Biotech Co., Ltd.NFY2026-04-16
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.NGM2026-04-16
16936983131640Multi-Drug Rapid Test Panel (Urine)Hangzhou AllTest Biotech Co., Ltd.NFW2026-04-16
10197344170203MEDLINEMEDLINE INDUSTRIES, INC.NFT2026-01-29
10197344170210MEDLINEMEDLINE INDUSTRIES, INC.NFT2026-01-23
10722066011260Rapid ResponseBTNX IncNGL2026-01-19
10722066011260Rapid ResponseBTNX IncNGM2026-01-19
10722066011260Rapid ResponseBTNX IncNGG2026-01-19
10722066011260Rapid ResponseBTNX IncNFY2026-01-19
10722066011260Rapid ResponseBTNX IncNFW2026-01-19
10722066011277Rapid ResponseBTNX IncNGL2026-01-19