FDA.reportPublic FDA data

Alltest Multi-Drug 4 Drugs Rapid Test Cup (Urine)

Primary DI
06936983153829
Brand
Alltest Multi-Drug 4 Drugs Rapid Test Cup (Urine)
Company
Hangzhou AllTest Biotech Co., Ltd.
Model
1
Catalog number
DOA-A144C-088-a
Device description
25T, FDA CLIA waived, MDMA500/OXY100/PCP25/BUP10
Published
2026-04-15
Public version status
Update
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
NGGTest, Methamphetamine, Over The Counter
NGLTest, Opiates, Over The Counter
NGMTest, Phencyclidine (Pcp), Over The Counter

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
NGGTest, Methamphetamine, Over The CounterClinical Toxicology2
NGLTest, Opiates, Over The CounterClinical Toxicology2
NGMTest, Phencyclidine (Pcp), Over The CounterUnknownU

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K233019000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K233019000AllTest Multi-Drug Rapid Test Cup; AllTest Multi-Drug Rapid Test Panel; AllTest Multi-Drug Rapid Test Cup Rx; AllTest Multi-Drug Rapid Test Panel RxHangzhou AllTest Biotech Co., Ltd.2023-12-13DKZ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
06936983153829PrimaryGS10
86936983153825Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
06936983153829069369831538296936983153829
8693698315382586936983153825

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
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
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
00311917077932WalgreensWALGREEN CO.NGL2026-10-14
00311917077932WalgreensWALGREEN CO.NGG2026-10-14
06937339211507BioSieveVivachek Biotech (Hangzhou) Co., Ltd.NGG2026-10-14
06937339211507BioSieveVivachek Biotech (Hangzhou) Co., Ltd.NGL2026-10-14
06937339211538BioSieveVivachek Biotech (Hangzhou) Co., Ltd.NGG2026-10-14
06937339211538BioSieveVivachek Biotech (Hangzhou) Co., Ltd.NGL2026-10-14
06974541566049BioTekeBioteke Corporation (Wuxi) Co., Ltd.NGM2026-10-13
06974541566049BioTekeBioteke Corporation (Wuxi) Co., Ltd.NGG2026-10-13
06974541566049BioTekeBioteke Corporation (Wuxi) Co., Ltd.NGL2026-10-13
06942598249383One Step® Buprenorphine (BUP10) Home Rapid Test DipstickHangzhou AllTest Biotech Co., Ltd.NGL2026-10-12
06942598249406One Step® Methamphetamine (MET500) Home Rapid Test DipstickHangzhou AllTest Biotech Co., Ltd.NGG2026-10-12
06942598249420One Step® Morphine (MOP/OPI2000) Home Rapid Test DipstickHangzhou AllTest Biotech Co., Ltd.NGL2026-10-12
10722066005511Rapid ResponseBTNX IncNGL2026-10-09
10722066005511Rapid ResponseBTNX IncNGG2026-10-09
10722066005511Rapid ResponseBTNX IncNGM2026-10-09
06936983113939Alltest MDMA500 Rapid Test Panel (Urine)Hangzhou AllTest Biotech Co., Ltd.NGG2026-04-21
06936983113946Alltest MET500 Rapid Test Panel (Urine)Hangzhou AllTest Biotech Co., Ltd.NGG2026-04-21
06936983113953Alltest MOP300 Rapid Test Panel (Urine)Hangzhou AllTest Biotech Co., Ltd.NGL2026-04-21
06936983113977Alltest MOP2000 Rapid Test Panel (Urine)Hangzhou AllTest Biotech Co., Ltd.NGL2026-04-21
06936983113984Alltest OXY100 Rapid Test Panel (Urine)Hangzhou AllTest Biotech Co., Ltd.NGL2026-04-21
06936983113991Alltest PCP25 Rapid Test Panel (Urine)Hangzhou AllTest Biotech Co., Ltd.NGM2026-04-21
06936983114042Alltest BUP10 Rapid Test Dipstick (Urine)Hangzhou AllTest Biotech Co., Ltd.NGL2026-04-21
06936983114080Alltest MDMA500 Rapid Test Dipstick (Urine)Hangzhou AllTest Biotech Co., Ltd.NGG2026-04-21
06936983114097Alltest MET500 Rapid Test Dipstick (Urine)Hangzhou AllTest Biotech Co., Ltd.NGG2026-04-21
06936983114103Alltest MOP300 Rapid Test Dipstick (Urine)Hangzhou AllTest Biotech Co., Ltd.NGL2026-04-21
06936983114127Alltest MOP2000 Rapid Test Dipstick (Urine)Hangzhou AllTest Biotech Co., Ltd.NGL2026-04-21
06936983114134Alltest OXY100 Rapid Test Dipstick (Urine)Hangzhou AllTest Biotech Co., Ltd.NGL2026-04-21
06936983114141Alltest PCP25 Rapid Test Dipstick (Urine)Hangzhou AllTest Biotech Co., Ltd.NGM2026-04-21
06936983114172Alltest MDMA500 Rapid Test Dipstick(Urine)-CLIA WaivedHangzhou AllTest Biotech Co., Ltd.NGG2026-04-21
06936983114202Alltest BUP10 Rapid Test Dipstick (Urine)-CLIA WaivedHangzhou AllTest Biotech Co., Ltd.NGL2026-04-21