FDA.reportPublic FDA data

Alltest EDDP300 Rapid Test Dipstick (Urine)

Primary DI
06936983114073
Brand
Alltest EDDP300 Rapid Test Dipstick (Urine)
Company
Hangzhou AllTest Biotech Co., Ltd.
Model
1
Catalog number
DED-A101 (300ng)
Device description
50T, for FDA POC
Published
2026-04-21
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
PTGTest, Methadone, Over The Counter

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
PTGTest, Methadone, 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
06936983114073PrimaryGS10
86936983114079Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
06936983114073069369831140736936983114073
8693698311407986936983114079

GMDN Terms#

Term, Definition table
TermDefinition
2-ethylidine-1,5-dimethyl-3,3-diphenylpyrrolidine (EDDP) IVD, reagentA substance or reactant intended to be used together with a parent IVD to perform a specific function in an assay that is used for the qualitative and/or quantitative detection of the methadone metabolite 2-ethylidine-1,5-dimethyl-3,3-diphenylpyrrolidine (EDDP) in a clinical specimen.

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
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
06978151200287Pocguide Multi-Drug Test Panel OTCHangzhou Aichek Medical Technology Co., Ltd.PTG2026-10-27
06978151200294Pocguide Multi-Drug Test Cup OTCHangzhou Aichek Medical Technology Co., Ltd.PTG2026-10-27
06937339211507BioSieveVivachek Biotech (Hangzhou) Co., Ltd.PTG2026-10-14
06937339211538BioSieveVivachek Biotech (Hangzhou) Co., Ltd.PTG2026-10-14
06974541566049BioTekeBioteke Corporation (Wuxi) Co., Ltd.PTG2026-10-13
06942598249413One Step® Methadone (MTD300) Home Rapid Test DipstickHangzhou AllTest Biotech Co., Ltd.PTG2026-10-12
10722066005511Rapid ResponseBTNX IncPTG2026-10-09
10722066018979Rapid ResponseBTNX IncPTG2026-10-08
10722066019013Rapid ResponseBTNX IncPTG2026-10-08
10722066019020Rapid ResponseBTNX IncPTG2026-10-08
10722066019037Rapid ResponseBTNX IncPTG2026-10-08
10722066019044Rapid ResponseBTNX IncPTG2026-10-08
10722066018955Rapid ResponseBTNX IncPTG2026-10-06
10722066018696Rapid ResponseBTNX IncPTG2026-09-18
06936983113960Alltest MTD300 Rapid Test Panel (Urine)Hangzhou AllTest Biotech Co., Ltd.PTG2026-04-21
06936983114110Alltest MTD300 Rapid Test Dipstick (Urine)Hangzhou AllTest Biotech Co., Ltd.PTG2026-04-21
06936983114233Alltest MTD300 Rapid Test Dipstick (Urine)-CLIA WaivedHangzhou AllTest Biotech Co., Ltd.PTG2026-04-21
06936983114288Alltest EDDP300 Rapid Test Dipstick (Urine)-CLIA WaivedHangzhou AllTest Biotech Co., Ltd.PTG2026-04-21
06936983114356Alltest EDDP300 Rapid Test Panel (Urine)-CLIA WaivedHangzhou AllTest Biotech Co., Ltd.PTG2026-04-21
06936983114387Alltest MTD300 Rapid Test Panel (Urine)-CLIA WaivedHangzhou AllTest Biotech Co., Ltd.PTG2026-04-21
06936983114479Alltest EDDP300 Home Rapid Test Dipstick (Urine)Hangzhou AllTest Biotech Co., Ltd.PTG2026-04-21
06936983114530Alltest MTD300 Home Rapid Test Dipstick (Urine)Hangzhou AllTest Biotech Co., Ltd.PTG2026-04-21
06936983114622Alltest EDDP300 Home Rapid Test Panel (Urine)Hangzhou AllTest Biotech Co., Ltd.PTG2026-04-21
06936983113922Alltest EDDP300 Rapid Test Panel (Urine)Hangzhou AllTest Biotech Co., Ltd.PTG2026-04-17
16936983131633Multi-Drug Rapid Test Panel (Urine)Hangzhou AllTest Biotech Co., Ltd.PTG2026-04-16
16936983131640Multi-Drug Rapid Test Panel (Urine)Hangzhou AllTest Biotech Co., Ltd.PTG2026-04-16
16936983138632Multi-Drug 12 Drugs Rapid Test CupHangzhou AllTest Biotech Co., Ltd.PTG2026-04-16
16936983141120Discover Multi-Drug 12 Drugs Rapid Test CupHangzhou AllTest Biotech Co., Ltd.PTG2026-04-16
16936983141137Discover Multi-Drug 12 Drugs Rapid Test CupHangzhou AllTest Biotech Co., Ltd.PTG2026-04-16
16936983144688Discover Multi-Drug 10 Drugs Rapid Test Cup (Urine)Hangzhou AllTest Biotech Co., Ltd.PTG2026-04-16