FDA.reportPublic FDA data

Alltest Multi-Drug 15 Drugs Rapid Test Cup (Urine)-CLIA Waived

Primary DI
06936983114806
Brand
Alltest Multi-Drug 15 Drugs Rapid Test Cup (Urine)-CLIA Waived
Company
Hangzhou AllTest Biotech Co., Ltd.
Model
1
Catalog number
DOA-A1157C-007-b-A1
Device description
25T, for FDA POC, MOP300/MOP2000/MDMA500/OXY100/EDDP300/PCP25/COC150/MTD300/BAR300/BZO300/AMP500/MET500/TCA1000/THC50/BUP10
Published
2026-04-16
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
true

Product Codes#

Code, Name table
CodeName
NFTTest, Amphetamine, Over The Counter
NFVTest, Benzodiazepine, Over The Counter
NFWTest, Cannabinoid, Over The Counter
NFYTest, Cocaine And Cocaine Metabolites, Over The Counter
NGGTest, Methamphetamine, Over The Counter
NGLTest, Opiates, Over The Counter
NGMTest, Phencyclidine (Pcp), 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
NFTTest, Amphetamine, Over The CounterClinical Toxicology2
NFVTest, Benzodiazepine, Over The CounterClinical Toxicology2
NFWTest, Cannabinoid, 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
NGMTest, Phencyclidine (Pcp), Over The CounterUnknownU
PTGTest, Methadone, Over The CounterClinical Toxicology2
PTHTest, Barbiturate, Over The CounterClinical Toxicology2
QAWTest, Tricyclic Antidepressants, Over The CounterClinical Toxicology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K182738000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K182738000Single and Multi-Drug Rapid Test Panel With Adulteration (Urine), Single and Multi-Drug Rapid Test Panel (Urine), Single and Multi-Drug Rapid Test Cup With Adulteration (Urine), Single and Multi-Drug Rapid Test Cup (Urine), Single Drug Rapid Test Dipstick (Urine), Single and Multi-Drug Home Rapid Test Panel (Urine), Single and Multi-Drug Home Rapid Test Cup (Urine), Single Drug Home Rapid Test Dipstick (Urine)Hangzhou AllTest Biotech Co., Ltd.2019-03-27DKZ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
06936983114806PrimaryGS10
86936983114802Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
06936983114806069369831148066936983114806
8693698311480286936983114802

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
50045611956013ept Pregnancy (hCG) Enhanced Sensitivity Rapid Test Midstream (Urine)1FHC-AU103H2026-10-29
50045611956044ept Digital Early Pregnancy Test Midstream(Urine)1FHC-AEU103H2026-10-29
00045611956049ept Digital Early Pregnancy Test Midstream(Urine)1FHC-AEU103H2026-10-27
00045611951013ept Pregnancy (hCG) Rapid Test Midstream (Urine)1FHC-A103H2026-10-26
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
G754QTUCUP10BU1QuikTox Ultra Cup Rapid Drug TestADVIN BIOTECH, INC.PTG2026-10-30
G754QTUCUP10BU1QuikTox Ultra Cup Rapid Drug TestADVIN BIOTECH, INC.NGG2026-10-30
G754QTUCUP10BU1QuikTox Ultra Cup Rapid Drug TestADVIN BIOTECH, INC.NFY2026-10-30
G754QTUCUP10BU1QuikTox Ultra Cup Rapid Drug TestADVIN BIOTECH, INC.NFV2026-10-30
G754QTUCUP10BU1QuikTox Ultra Cup Rapid Drug TestADVIN BIOTECH, INC.NGL2026-10-30
G754QTUCUP10BU1QuikTox Ultra Cup Rapid Drug TestADVIN BIOTECH, INC.PTH2026-10-30
G754QTUCUP10BU1QuikTox Ultra Cup Rapid Drug TestADVIN BIOTECH, INC.NFT2026-10-30
G754QTUCUP10BU1QuikTox Ultra Cup Rapid Drug TestADVIN BIOTECH, INC.NGM2026-10-30
G754QTUCUP5C31QuikTox Ultra Cup Rapid Drug TestADVIN BIOTECH, INC.NGL2026-10-30
G754QTUCUP5C31QuikTox Ultra Cup Rapid Drug TestADVIN BIOTECH, INC.NFT2026-10-30
G754QTUCUP5C31QuikTox Ultra Cup Rapid Drug TestADVIN BIOTECH, INC.NFY2026-10-30
G754QTUCUP5C31QuikTox Ultra Cup Rapid Drug TestADVIN BIOTECH, INC.NGG2026-10-30
G754QTUCUP5C31QuikTox Ultra Cup Rapid Drug TestADVIN BIOTECH, INC.NFW2026-10-30
06978151200287Pocguide Multi-Drug Test Panel OTCHangzhou Aichek Medical Technology Co., Ltd.NGM2026-10-27
06978151200287Pocguide Multi-Drug Test Panel OTCHangzhou Aichek Medical Technology Co., Ltd.NFT2026-10-27
06978151200287Pocguide Multi-Drug Test Panel OTCHangzhou Aichek Medical Technology Co., Ltd.NGL2026-10-27
06978151200287Pocguide Multi-Drug Test Panel OTCHangzhou Aichek Medical Technology Co., Ltd.PTH2026-10-27
06978151200287Pocguide Multi-Drug Test Panel OTCHangzhou Aichek Medical Technology Co., Ltd.NFV2026-10-27
06978151200287Pocguide Multi-Drug Test Panel OTCHangzhou Aichek Medical Technology Co., Ltd.NFY2026-10-27
06978151200287Pocguide Multi-Drug Test Panel OTCHangzhou Aichek Medical Technology Co., Ltd.NGG2026-10-27
06978151200287Pocguide Multi-Drug Test Panel OTCHangzhou Aichek Medical Technology Co., Ltd.PTG2026-10-27
06978151200287Pocguide Multi-Drug Test Panel OTCHangzhou Aichek Medical Technology Co., Ltd.NFW2026-10-27
06978151200287Pocguide Multi-Drug Test Panel OTCHangzhou Aichek Medical Technology Co., Ltd.QAW2026-10-27
06978151200294Pocguide Multi-Drug Test Cup OTCHangzhou Aichek Medical Technology Co., Ltd.QAW2026-10-27
06978151200294Pocguide Multi-Drug Test Cup OTCHangzhou Aichek Medical Technology Co., Ltd.NFW2026-10-27
06978151200294Pocguide Multi-Drug Test Cup OTCHangzhou Aichek Medical Technology Co., Ltd.NGM2026-10-27
06978151200294Pocguide Multi-Drug Test Cup OTCHangzhou Aichek Medical Technology Co., Ltd.PTG2026-10-27
06978151200294Pocguide Multi-Drug Test Cup OTCHangzhou Aichek Medical Technology Co., Ltd.NGG2026-10-27
06978151200294Pocguide Multi-Drug Test Cup OTCHangzhou Aichek Medical Technology Co., Ltd.NFY2026-10-27
06978151200294Pocguide Multi-Drug Test Cup OTCHangzhou Aichek Medical Technology Co., Ltd.NFV2026-10-27