FDA.reportPublic FDA data

DrugTect Multi-Drug Rapid Test Cup

Primary DI
06942598201671
Brand
DrugTect Multi-Drug Rapid Test Cup
Company
Hangzhou AllTest Biotech Co., Ltd.
Model
DT-AT14-AD6-1-AZ25
Device description
DrugTect, 14 Panel Multi-Drug Test Cup, CLIA WAIVED (AMP500, BAR300, BUP10, BZO300, COC150, FYL1, MDMA500, MET500, MOP300, MTD300 OXY100, PCP25, TCA1000, THC50) + (OX, SG, PH) + (NIT, GUL, CRE) Contents: Test Cups - 25, Package Insert - 1, Adulteration Color Chart - 1, Security Seals – 25. For In Vitro Diagnostics Use
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
NGITest, Morphine, Over The Counter

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
NGITest, Morphine, Over The CounterClinical Toxicology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
16942598201678PrimaryGS10
06942598201671Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
1694259820167816942598201678
06942598201671069425982016716942598201671

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
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
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
16942598226046Identify Diagnostics Multi-Drug Test Cup Hangzhou AllTest Biotech Co., Ltd.NGI2026-04-08
16942598201654DrugTect Multi-Drug Rapid Test CupHangzhou AllTest Biotech Co., Ltd.NGI2025-11-15
16942598201661DrugTect Multi-Drug Rapid Test CupHangzhou AllTest Biotech Co., Ltd.NGI2025-11-15
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16942598201692DrugTect Multi-Drug Rapid Test CupHangzhou AllTest Biotech Co., Ltd.NGI2025-11-15
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16942598201715DrugTect Multi-Drug Rapid Test CupHangzhou AllTest Biotech Co., Ltd.NGI2025-11-15
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16942598201760DrugTect Multi-Drug Rapid Test CupHangzhou AllTest Biotech Co., Ltd.NGI2025-11-15
16942598201777DrugTect Multi-Drug Rapid Test CupHangzhou AllTest Biotech Co., Ltd.NGI2025-11-15
16942598201784DrugTect Multi-Drug Rapid Test CupHangzhou AllTest Biotech Co., Ltd.NGI2025-11-15
16942598201807DrugTect Multi-Drug Urine Test CupHangzhou AllTest Biotech Co., Ltd.NGI2025-11-15
16942598201814DrugTect Multi-Drug Urine Test CupHangzhou AllTest Biotech Co., Ltd.NGI2025-11-15
16942598201821DrugTect Multi-Drug Urine Test CupHangzhou AllTest Biotech Co., Ltd.NGI2025-11-15
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16942598201845DrugTect Multi-Drug Urine Test CupHangzhou AllTest Biotech Co., Ltd.NGI2025-11-15
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06942598201688DrugTect Multi-Drug Rapid Test CupHangzhou AllTest Biotech Co., Ltd.NGI2025-11-15
16942598201722DrugTect Multi-Drug Rapid Test CupHangzhou AllTest Biotech Co., Ltd.NGI2025-11-15
16942598201791DrugTect Multi-Drug Urine Test CupHangzhou AllTest Biotech Co., Ltd.NGI2025-11-15
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