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
00850076289706HYSEN Multiple Drugs Test CupHYSEN INC.NFW2026-07-20
00850076289713HYSEN Multiple Drugs Test CupHYSEN INC.NFW2026-07-20
G474M2105010mLife Rapid Drug TestMlife Diagnostics, LLCNFW2026-07-20
G474M2107010mLife Rapid Drug TestMlife Diagnostics, LLCNFW2026-07-20
G474M2113010mLife Rapid Drug TestMlife Diagnostics, LLCNFW2026-07-20
G474M2116010mLife Rapid Drug TestMlife Diagnostics, LLCNFW2026-07-20
G474M2117010mLife Rapid Drug TestMlife Diagnostics, LLCNFW2026-07-20
10722066018009Rapid ResponseBTNX IncNFW2026-07-14
10858886006855Noble Drug Test Cup with AD (Urine)NOBLE MEDICAL INCNFW2026-07-09
00810174471229Prime Screen®WONDFO USA CO., LTD.NFW2026-06-26
00810174471410Prime Screen®WONDFO USA CO., LTD.NFW2026-06-26
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
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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
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16936983141137Discover Multi-Drug 12 Drugs Rapid Test Cup Hangzhou AllTest Biotech Co., Ltd.NFW2026-04-16
16936983144688Discover Multi-Drug 10 Drugs Rapid Test Cup (Urine)Hangzhou AllTest Biotech Co., Ltd.NFW2026-04-16
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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