FDA.reportPublic FDA data

Atida Marijuana (THC) Drug of Abuse Rapid Urine Dip Card

Primary DI
80810164510743
Brand
Atida Marijuana (THC) Drug of Abuse Rapid Urine Dip Card
Company
ACESO LABORATORIES INC.
Model
U04CW-THC-US
Device description
25T, FDA
Published
2026-03-23
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
true
Sterile
false
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

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K242540000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K242540000AllTest Multi-Drug Urine Test Panel; AllTest Multi-Drug Rapid Urine Test PanelHangzhou AllTest Biotech Co., Ltd.2024-09-27NFT

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00810164510747PrimaryGS10
80810164510743Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00810164510747008101645107478101645107470810164510747
8081016451074380810164510743

GMDN Terms#

Term, Definition table
TermDefinition
Cannabinoid/cannabinoid metabolite 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 cannabinoids and/or cannabinoid metabolites (i.e., natural, synthetic) 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
003099455
Device count
25
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00810164510013ACESO Early Pregnancy TestU03ST-UHCG-US2026-03-23
00810164510020ACESO Early Pregnancy TestU03ST-UHCG-US2026-03-23
00810164510037ACESO Early Pregnancy TestU03ST-UHCG-US2026-03-23
00810164510044ACESO Early Pregnancy TestU03ST-UHCG-US2026-03-23
00810164510051ACESO Early Pregnancy TestU03ST-UHCG-US2026-03-23
00810164510068ACESO Early Pregnancy TestU03ST-UHCG-US2026-03-23
00810164510075Atida Fentanyl Drug of Abuse Test RxU02-FYL-US2026-03-23
00810164510082Atida Fentanyl Drug of Abuse Test U02CW-FYL-US2026-03-23
00810164510105Atida hCG Pregnancy Rapid Combo TestUS02-HCG-US2026-03-23
00810164510730Atida Marijuana (THC) Drug of Abuse Strip Test RxU01CW-THC-US2026-03-23
00810164510747Atida Marijuana (THC) Drug of Abuse Rapid Urine Dip CardU04CW-THC-US2026-03-23
00810164510815Atida Viral Transport Medium (Non-inactivated Type)Q01-VTM-US2026-03-23
00810164510006ACESO Early Pregnancy TestU03ST-UHCG-US2026-03-23
80810164510019ACESO Early Pregnancy TestU03ST-UHCG-US2026-03-23
80810164510026ACESO Early Pregnancy TestU03ST-UHCG-US2026-03-23
80810164510033ACESO Early Pregnancy TestU03ST-UHCG-US2026-03-23
80810164510040ACESO Early Pregnancy TestU03ST-UHCG-US2026-03-23
80810164510057ACESO Early Pregnancy TestU03ST-UHCG-US2026-03-23
80810164510064ACESO Early Pregnancy TestU03ST-UHCG-US2026-03-23
80810164510071Atida Fentanyl Drug of Abuse Test RxU02-FYL-US2026-03-23

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