FDA.reportPublic FDA data

DrugTect Multi-Drug Rapid Test Cup

Primary DI
06942598201688
Brand
DrugTect Multi-Drug Rapid Test Cup
Company
Hangzhou AllTest Biotech Co., Ltd.
Model
DT-AT14-AD6-1-AZ50
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 - 50, Package Insert - 1, Adulteration Color Chart - 1, Security Seals – 50. 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
16942598201685PrimaryGS10
06942598201688Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
1694259820168516942598201685
06942598201688069425982016886942598201688

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
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
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16942598201692DrugTect 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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16942598201647DrugTect Multi-Drug Rapid Test CupHangzhou AllTest Biotech Co., Ltd.NGI2025-11-15
06942598201671DrugTect 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
06977469280189U-Catch XR Multi-Drug Test Cup(Colloidal Gold)Eterbio, Inc.NGI2024-12-18
06977469280004U-Catch PLUS Multi-Drug Test Cup(Colloidal Gold)Eterbio, Inc.NGI2024-12-17
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