FDA.reportPublic FDA data

CVS Health

Primary DI
00050428400906
Brand
CVS Health
Company
WOONSOCKET PRESCRIPTION CENTER, INCORPORATED
Model
440368
Device description
1 At-Home Drug Test Kit - Marijuana (THC50)
Published
2023-08-23
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
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
00050428400906PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00050428400906000504284009060504284009060050428400906

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.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
062312574
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00050428143315CVSCVS489905V22026-09-18
00050428340561CVSCVS469682V22026-09-18
00050428269381CVS Health9965529965522016-09-21
00050428339770CVS Health16CVS01507NEW3291982026-03-20
00050428143216CVS0504281432162026-08-18
00050428124505CVS Health8448202026-08-14
00050428034873CVS Health5518372026-08-08
00050428034880CVS Health5518362026-08-08
00050428167335CVSMD300CN330R2026-07-10
00050428167342CVSMD300C2052026-07-10
00050428426777CVS HealthCVS991268RR2026-06-24
00050428005873CVS695540BC332025-11-19
00050428280669CVS HealthCVS5248V12026-06-04
00050428359112CVS HealthCVS739091V12026-06-04
00050428453599CVS HealthCVS9107552026-06-04
10050428265106CVS Glucose Meter8000-107532021-03-22
00050428050460CVS Health6 Days Sooner Pregnancy TestN/A2026-06-03
00050428082102CVS Health6 Days Sooner Pregnancy TestN/A2026-06-03
00050428087268CVS Health6 Days Sooner Pregnancy TestN/A2026-06-03
00050428087589CVS Health6 Days Sooner Pregnancy TestN/A2026-06-03

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10722066018955Rapid ResponseBTNX IncNFW2026-10-06
10722066018696Rapid ResponseBTNX IncNFW2026-09-18
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