FDA.reportPublic FDA data

DrugConfirm

Primary DI
00856464008416
Brand
DrugConfirm
Company
CONFIRM BIOSCIENCES, INC.
Model
CB-DC-1PanelOTC
Device description
1 Drug Tested Home Drug Test (THC)
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
00856464008416PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00856464008416008564640084168564640084160856464008416

GMDN Terms#

Term, Definition table
TermDefinition
Cannabinoid 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 cannabinoids in a clinical specimen.

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
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
G474M210501EI0mLife Rapid Drug TestMlife Diagnostics, LLCNFW2026-08-14
00840050500170OneScreenAMERICAN SCREENING, L.L.C.NFW2022-11-11
00840050500187OneScreenAMERICAN SCREENING, L.L.C.NFW2022-11-11
00840050500194OneScreenAMERICAN SCREENING, L.L.C.NFW2022-11-11
00840050500200OneScreenAMERICAN SCREENING, L.L.C.NFW2022-11-11
00840050500217OneScreenAMERICAN SCREENING, L.L.C.NFW2022-11-11
00840050500224OneScreenAMERICAN SCREENING, L.L.C.NFW2022-11-11
00840050500231OneScreenAMERICAN SCREENING, L.L.C.NFW2022-11-11
00840050500248OneScreenAMERICAN SCREENING, L.L.C.NFW2022-11-11
00840050500255OneScreenAMERICAN SCREENING, L.L.C.NFW2022-11-11
00840050500262OneScreenAMERICAN SCREENING, L.L.C.NFW2022-11-11
00840050500279OneScreenAMERICAN SCREENING, L.L.C.NFW2022-11-11
00840050500286OneScreenAMERICAN SCREENING, L.L.C.NFW2022-11-11
00840050500293OneScreenAMERICAN SCREENING, L.L.C.NFW2022-11-11
00840050500309OneScreenAMERICAN SCREENING, L.L.C.NFW2022-11-11
00840050500316OneScreenAMERICAN SCREENING, L.L.C.NFW2022-11-11
00840050500323OneScreenAMERICAN SCREENING, L.L.C.NFW2022-11-11
00840050500330OneScreenAMERICAN SCREENING, L.L.C.NFW2022-11-11
00840050500347OneScreenAMERICAN SCREENING, L.L.C.NFW2022-11-11
00840050500354OneScreenAMERICAN SCREENING, L.L.C.NFW2022-11-11
00840050500361OneScreenAMERICAN SCREENING, L.L.C.NFW2022-11-11
00840050500378OneScreenAMERICAN SCREENING, L.L.C.NFW2022-11-11
00840050500385OneScreenAMERICAN SCREENING, L.L.C.NFW2022-11-11
00840050500392OneScreenAMERICAN SCREENING, L.L.C.NFW2022-11-11
00840050500408OneScreenAMERICAN SCREENING, L.L.C.NFW2022-11-11
00840050500415OneScreenAMERICAN SCREENING, L.L.C.NFW2022-11-11
00840050500422OneScreenAMERICAN SCREENING, L.L.C.NFW2022-11-11
00840050500439OneScreenAMERICAN SCREENING, L.L.C.NFW2022-11-11
00840050500446OneScreenAMERICAN SCREENING, L.L.C.NFW2022-11-11
00840050500453OneScreenAMERICAN SCREENING, L.L.C.NFW2022-11-11