FDA.reportPublic FDA data

DrugTect Multi-Drug Test Cup

Primary DI
16942598203795
Brand
DrugTect Multi-Drug Test Cup
Company
Hangzhou AllTest Biotech Co., Ltd.
Model
DT-AT13-AD6-1-AZ25
Catalog number
DUA-A1137C
Device description
25T, FDA CLIA Waived, AMP500/BAR300/BUP10/BZO300/COC150/EDDP300/FYL1/MDMA500/MET500/OPI300/MTD300/OXY100/TCA1000+(OXI/SG/PH)+(NIT/GLU/CRE)
Published
2026-04-08
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
CENDye-Indicator, Ph (Urinary, Non-Quantitative)
JMTDiazo (Colorimetric), Nitrite (Urinary, Non-Quant)
LJXTest, Urine Leukocyte
NFTTest, Amphetamine, Over The Counter
NFVTest, Benzodiazepine, Over The Counter
NFYTest, Cocaine And Cocaine Metabolites, Over The Counter
NGGTest, Methamphetamine, Over The Counter
NGLTest, Opiates, Over The Counter
PTGTest, Methadone, Over The Counter
PTHTest, Barbiturate, Over The Counter
QAWTest, Tricyclic Antidepressants, Over The Counter

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
CENDye-Indicator, Ph (Urinary, Non-Quantitative)Clinical Chemistry1
JMTDiazo (Colorimetric), Nitrite (Urinary, Non-Quant)Clinical Chemistry1
LJXTest, Urine LeukocyteHematology1
NFTTest, Amphetamine, Over The CounterClinical Toxicology2
NFVTest, Benzodiazepine, Over The CounterClinical Toxicology2
NFYTest, Cocaine And Cocaine Metabolites, Over The CounterClinical Toxicology2
NGGTest, Methamphetamine, Over The CounterClinical Toxicology2
NGLTest, Opiates, Over The CounterClinical Toxicology2
PTGTest, Methadone, Over The CounterClinical Toxicology2
PTHTest, Barbiturate, Over The CounterClinical Toxicology2
QAWTest, Tricyclic Antidepressants, Over The CounterClinical Toxicology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
16942598203795PrimaryGS10
06942598203798Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
1694259820379516942598203795
06942598203798069425982037986942598203798

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.

Regulatory Flags#

DUNS number
543254717
Device count
25
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
06936983113793Alltest Pregnancy Rapid Combo Test Cassette(Urine/Serum)1FHC-A2022026-04-22
06936983113809Alltest Pregnancy Rapid Combo Test Cassette(Urine/Serum)1FHC-A2022026-04-22
06936983114721Alltest BZO300 Home Rapid Test Panel (Urine)1DBZ-A114H (300ng)2026-04-22
06936983114738Alltest BAR300 Home Rapid Test Panel (Urine)1DBA-A114H (300ng)2026-04-22
06936983114745Alltest AMP500 Home Rapid Test Panel (Urine)1DAM-A114H (500ng)2026-04-22
06936983114752Alltest MOP2000 Home Rapid Test Panel(Urine)1DOP-A114H (2000ng)2026-04-22
06936983114769Alltest MOP300 Home Rapid Test Panel (Urine)1DMO-A114H (300ng)2026-04-22
06936983113939Alltest MDMA500 Rapid Test Panel (Urine)1DMD-A114 (500ng)2026-04-21
06936983113946Alltest MET500 Rapid Test Panel (Urine)1DME-A114 (500ng)2026-04-21
06936983113953Alltest MOP300 Rapid Test Panel (Urine)1DMO-A114 (300ng)2026-04-21
06936983113960Alltest MTD300 Rapid Test Panel (Urine)1DMT-A114 (300ng)2026-04-21
06936983113977Alltest MOP2000 Rapid Test Panel (Urine)1DOP-A114 (2000ng)2026-04-21
06936983113984Alltest OXY100 Rapid Test Panel (Urine)1DOX-A114 (100ng)2026-04-21
06936983113991Alltest PCP25 Rapid Test Panel (Urine)1DPC-A114 (25ng)2026-04-21
06936983114004Alltest TCA1000 Rapid Test Panel (Urine)1DTC-A114 (1000ng)2026-04-21
06936983114011Alltest THC50 Rapid Test Panel (Urine)1DTH-A114 (50ng)2026-04-21
06936983114028Alltest AMP500 Rapid Test Dipstick (Urine)1DAM-A101 (500ng)2026-04-21
06936983114035Alltest BAR300 Rapid Test Dipstick (Urine)1DBA-A101 (300ng)2026-04-21
06936983114042Alltest BUP10 Rapid Test Dipstick (Urine)1DBU-A101 (10ng)2026-04-21
06936983114059Alltest BZO300 Rapid Test Dipstick (Urine)1DBZ-A101 (300ng)2026-04-21

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
06935740751773Urine StripsUrit Medical Electronic Co., Ltd.CEN2026-06-03
06935740751773Urine StripsUrit Medical Electronic Co., Ltd.LJX2026-06-03
06935740751773Urine StripsUrit Medical Electronic Co., Ltd.JMT2026-06-03
06935740751780URINE REAGENT STRIPSUrit Medical Electronic Co., Ltd.LJX2026-06-03
06935740751780URINE REAGENT STRIPSUrit Medical Electronic Co., Ltd.JMT2026-06-03
06935740751780URINE REAGENT STRIPSUrit Medical Electronic Co., Ltd.CEN2026-06-03
06935740751797URINE REAGENT STRIPSUrit Medical Electronic Co., Ltd.CEN2026-06-03
06935740751797URINE REAGENT STRIPSUrit Medical Electronic Co., Ltd.JMT2026-06-03
06935740751797URINE REAGENT STRIPSUrit Medical Electronic Co., Ltd.LJX2026-06-03
06935740751803Urine StripsUrit Medical Electronic Co., Ltd.LJX2026-06-03
06935740751803Urine StripsUrit Medical Electronic Co., Ltd.JMT2026-06-03
06935740751803Urine StripsUrit Medical Electronic Co., Ltd.CEN2026-06-03
06935740751810Urine StripsUrit Medical Electronic Co., Ltd.JMT2026-06-03
06935740751810Urine StripsUrit Medical Electronic Co., Ltd.LJX2026-06-03
06935740751810Urine StripsUrit Medical Electronic Co., Ltd.CEN2026-06-03
06935740751827URINE REAGENT STRIPSUrit Medical Electronic Co., Ltd.JMT2026-06-03
06935740751827URINE REAGENT STRIPSUrit Medical Electronic Co., Ltd.CEN2026-06-03
06935740751827URINE REAGENT STRIPSUrit Medical Electronic Co., Ltd.LJX2026-06-03
06935740751834Urine StripsUrit Medical Electronic Co., Ltd.LJX2026-06-03
06935740751834Urine StripsUrit Medical Electronic Co., Ltd.JMT2026-06-03
06935740751834Urine StripsUrit Medical Electronic Co., Ltd.CEN2026-06-03
06935740751841Urine AnalyzerUrit Medical Electronic Co., Ltd.JMT2026-06-03
06935740751841Urine AnalyzerUrit Medical Electronic Co., Ltd.LJX2026-06-03
06935740751841Urine AnalyzerUrit Medical Electronic Co., Ltd.CEN2026-06-03
06935740751858Urine AnalyzerUrit Medical Electronic Co., Ltd.CEN2026-06-03
06935740751858Urine AnalyzerUrit Medical Electronic Co., Ltd.LJX2026-06-03
06935740751858Urine AnalyzerUrit Medical Electronic Co., Ltd.JMT2026-06-03
06935740751865URINE ANALYZERUrit Medical Electronic Co., Ltd.JMT2026-06-03
06935740751865URINE ANALYZERUrit Medical Electronic Co., Ltd.LJX2026-06-03
06935740751865URINE ANALYZERUrit Medical Electronic Co., Ltd.CEN2026-06-03