FDA.reportPublic FDA data

DrugTect Multi-Drug Urine Test Cup

Primary DI
06942598201824
Brand
DrugTect Multi-Drug Urine Test Cup
Company
Hangzhou AllTest Biotech Co., Ltd.
Model
DT-AT18-FLAT-1-AZ50
Device description
DrugTect ,18 Panel Multi-Drug Rapid Urine Test Cup, CLIA WAIVED (6-MAM10, AMP500, BAR300, BUP10,BZO300, COC150, EDDP300, FYL1,MDMA500, MET500, MOP300, MTD300,OXY100, PCP25, PPX300, TCA1000, THC50,TRA100) Contents: Test Cups - 50, Package Insert - 1, Security seals - 50. For In Vitro Diagnostic Use Only.
Published
2025-11-15
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
NFTTest, Amphetamine, Over The Counter

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
NFTTest, Amphetamine, Over The CounterClinical Toxicology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K250727000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K250727000AllTest Multi-Drug Rapid Urine Test Cup; AllTest Multi-Drug Urine Test CupHangzhou AllTest Biotech Co., Ltd.2025-04-04NFT

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
16942598201821PrimaryGS10
06942598201824Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
1694259820182116942598201821
06942598201824069425982018246942598201824

GMDN Terms#

Term, Definition table
TermDefinition
Multiple drugs of abuse 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 multiple drugs of abuse 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
543254717
Device count
50
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
false
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
06942598249376One Step® Fentanyl(FYL1) Urine Test Panel1DFY-A114H2026-10-12
06942598249383One Step® Buprenorphine (BUP10) Home Rapid Test Dipstick1DBU-A101H2026-10-12
06942598249390One Step® Benzodiazepines (BZO300) Home Rapid Test Dipstick1DBZ-A101H2026-10-12
06942598249406One Step® Methamphetamine (MET500) Home Rapid Test Dipstick1DME-A101H2026-10-12
06942598249413One Step® Methadone (MTD300) Home Rapid Test Dipstick1DMT-A101H2026-10-12
06942598249420One Step® Morphine (MOP/OPI2000) Home Rapid Test Dipstick1DOP-A101H2026-10-12
16936983131633Multi-Drug Rapid Test Panel (Urine)1DOA-A1104C2026-04-16
16936983131640Multi-Drug Rapid Test Panel (Urine)1DOA-A1124C2026-04-16
16936983138632Multi-Drug 12 Drugs Rapid Test Cup1DOA-A1127C-062-b-A32026-04-16
16936983141120Discover Multi-Drug 12 Drugs Rapid Test Cup1DUA-A1127C-A32026-04-16
16936983141137Discover Multi-Drug 12 Drugs Rapid Test Cup1DUA-A1127C-A32026-04-16
16936983144664DiscoverDISP-CUP164N$2023-11-30
16936983144671DiscoverDISP-DUD6144N$2023-11-30
16936983144688Discover Multi-Drug 10 Drugs Rapid Test Cup (Urine)1DOA-A1107C-A32026-04-16
16936983149744Discover milti-drug 7 drugs rapid test cupDUA-A177C-A3 A1617DISP-DUD774N$2024-02-08
16936983153819Discover Multi-Drug 13 Drugs Rapid Test Cup (Urine)1DUA-A1137C-A32026-04-15
16936983165379Discover Multi-Drug 5 Drugs Rapid Test Cup(Urine)1DUA-A157C-A32026-04-15
16936983169599Alltest Multi-Drug Rapid Urine Test Panel1DOA-A1144C-026-b2026-04-15
16936983169605Alltest Multi-Drug Rapid Urine Test Panel1DUA-A1144C-003-b2026-04-15
16936983169865Discover Multi-Drug 6 Drugs Rapid Test Cup (Urine)1DUA-A167C-A32026-04-15

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
06937339211507BioSieveVivachek Biotech (Hangzhou) Co., Ltd.NFT2026-10-14
06937339211538BioSieveVivachek Biotech (Hangzhou) Co., Ltd.NFT2026-10-14
06974541566049BioTekeBioteke Corporation (Wuxi) Co., Ltd.NFT2026-10-13
G474M210501EI0mLife Rapid Drug TestMlife Diagnostics, LLCNFT2026-08-14
06936983114028Alltest AMP500 Rapid Test Dipstick (Urine)Hangzhou AllTest Biotech Co., Ltd.NFT2026-04-21
06936983114196Alltest AMP500 Rapid Test Dipstick (Urine)-CLIA WaivedHangzhou AllTest Biotech Co., Ltd.NFT2026-04-21
06936983114455Alltest AMP500 Rapid Test Panel (Urine)-CLIA WaivedHangzhou AllTest Biotech Co., Ltd.NFT2026-04-21
06936983114592Alltest AMP500 Home Rapid Test Dipstick (Urine)Hangzhou AllTest Biotech Co., Ltd.NFT2026-04-21
06936983114608Alltest AMP500 Home Rapid Test Dipstick (Urine)Hangzhou AllTest Biotech Co., Ltd.NFT2026-04-21
06936983113878Alltest AMP500 Rapid Test Panel (Urine)Hangzhou AllTest Biotech Co., Ltd.NFT2026-04-17
16936983131633Multi-Drug Rapid Test Panel (Urine)Hangzhou AllTest Biotech Co., Ltd.NFT2026-04-16
16936983131640Multi-Drug Rapid Test Panel (Urine)Hangzhou AllTest Biotech Co., Ltd.NFT2026-04-16
16936983138632Multi-Drug 12 Drugs Rapid Test CupHangzhou AllTest Biotech Co., Ltd.NFT2026-04-16
16936983141120Discover Multi-Drug 12 Drugs Rapid Test CupHangzhou AllTest Biotech Co., Ltd.NFT2026-04-16
16936983141137Discover Multi-Drug 12 Drugs Rapid Test CupHangzhou AllTest Biotech Co., Ltd.NFT2026-04-16
16936983144688Discover Multi-Drug 10 Drugs Rapid Test Cup (Urine)Hangzhou AllTest Biotech Co., Ltd.NFT2026-04-16
06936983114790Alltest Multi-Drug 15 Drugs Rapid Test Panel (Urine)-CLIA WaivedHangzhou AllTest Biotech Co., Ltd.NFT2026-04-16
06936983114806Alltest Multi-Drug 15 Drugs Rapid Test Cup (Urine)-CLIA WaivedHangzhou AllTest Biotech Co., Ltd.NFT2026-04-16
06936983114813Alltest Multi-Drug 15 Drugs Rapid Test Cup (Urine)-CLIA WaivedHangzhou AllTest Biotech Co., Ltd.NFT2026-04-16
06936983114820Alltest Multi-Drug 12 Drugs Rapid Test Cup (Urine)-CLIA WaivedHangzhou AllTest Biotech Co., Ltd.NFT2026-04-16
06936983114837Alltest Multi-Drug 12 Drugs Rapid Test Cup (Urine)-CLIA WaivedHangzhou AllTest Biotech Co., Ltd.NFT2026-04-16
06936983114844Alltest Multi-Drug 12 Drugs Rapid Test Cup (Urine)-CLIA WaivedHangzhou AllTest Biotech Co., Ltd.NFT2026-04-16
06936983114868Alltest Multi-Drug 15 Drugs Rapid Test Cup (Urine)Hangzhou AllTest Biotech Co., Ltd.NFT2026-04-16
06936983114875Alltest Multi-Drug 15 Drugs Rapid Test Panel (Urine)Hangzhou AllTest Biotech Co., Ltd.NFT2026-04-16
06936983118064Alltest Multi-Drug 12 Drugs Home Rapid Test Cup (Urine)Hangzhou AllTest Biotech Co., Ltd.NFT2026-04-16
06936983118071Alltest Multi-Drug 12 Drugs Home Rapid Test Cup (Urine)Hangzhou AllTest Biotech Co., Ltd.NFT2026-04-16
06936983125123Multi-Drug 12 Drugs Rapid Test Cup (Urine)Hangzhou AllTest Biotech Co., Ltd.NFT2026-04-16
16936983153819Discover Multi-Drug 13 Drugs Rapid Test Cup (Urine)Hangzhou AllTest Biotech Co., Ltd.NFT2026-04-15
16936983165379Discover Multi-Drug 5 Drugs Rapid Test Cup(Urine)Hangzhou AllTest Biotech Co., Ltd.NFT2026-04-15
16936983169599Alltest Multi-Drug Rapid Urine Test PanelHangzhou AllTest Biotech Co., Ltd.NFT2026-04-15