FDA.reportPublic FDA data

Alltest BAR300 Home Rapid Test Panel (Urine)

Primary DI
06936983114738
Brand
Alltest BAR300 Home Rapid Test Panel (Urine)
Company
Hangzhou AllTest Biotech Co., Ltd.
Model
1
Catalog number
DBA-A114H (300ng)
Device description
1T, for FDA
Published
2026-04-22
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
PTHTest, Barbiturate, Over The Counter

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
PTHTest, Barbiturate, 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
06936983114738PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
06936983114738069369831147386936983114738

GMDN Terms#

Term, Definition table
TermDefinition
Barbiturate 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 barbiturates 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
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
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
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
06978151200287Pocguide Multi-Drug Test Panel OTCHangzhou Aichek Medical Technology Co., Ltd.PTH2026-10-27
06978151200294Pocguide Multi-Drug Test Cup OTCHangzhou Aichek Medical Technology Co., Ltd.PTH2026-10-27
06937339211507BioSieveVivachek Biotech (Hangzhou) Co., Ltd.PTH2026-10-14
06937339211538BioSieveVivachek Biotech (Hangzhou) Co., Ltd.PTH2026-10-14
06974541566049BioTekeBioteke Corporation (Wuxi) Co., Ltd.PTH2026-10-13
10722066005511Rapid ResponseBTNX IncPTH2026-10-09
10722066018979Rapid ResponseBTNX IncPTH2026-10-08
10722066019013Rapid ResponseBTNX IncPTH2026-10-08
10722066019020Rapid ResponseBTNX IncPTH2026-10-08
10722066019037Rapid ResponseBTNX IncPTH2026-10-08
10722066019044Rapid ResponseBTNX IncPTH2026-10-08
10722066018955Rapid ResponseBTNX IncPTH2026-10-06
10722066018696Rapid ResponseBTNX IncPTH2026-09-18
06936983114035Alltest BAR300 Rapid Test Dipstick (Urine)Hangzhou AllTest Biotech Co., Ltd.PTH2026-04-21
06936983114219Alltest BAR300 Rapid Test Dipstick (Urine)-CLIA WaivedHangzhou AllTest Biotech Co., Ltd.PTH2026-04-21
06936983114332Alltest BAR300 Rapid Test Panel (Urine)-CLIA WaivedHangzhou AllTest Biotech Co., Ltd.PTH2026-04-21
06936983114585Alltest BAR300 Home Rapid Test Dipstick (Urine)Hangzhou AllTest Biotech Co., Ltd.PTH2026-04-21
06936983113885Alltest BAR300 Rapid Test Panel (Urine)Hangzhou AllTest Biotech Co., Ltd.PTH2026-04-17
16936983131633Multi-Drug Rapid Test Panel (Urine)Hangzhou AllTest Biotech Co., Ltd.PTH2026-04-16
16936983131640Multi-Drug Rapid Test Panel (Urine)Hangzhou AllTest Biotech Co., Ltd.PTH2026-04-16
16936983138632Multi-Drug 12 Drugs Rapid Test CupHangzhou AllTest Biotech Co., Ltd.PTH2026-04-16
16936983141120Discover Multi-Drug 12 Drugs Rapid Test CupHangzhou AllTest Biotech Co., Ltd.PTH2026-04-16
16936983141137Discover Multi-Drug 12 Drugs Rapid Test CupHangzhou AllTest Biotech Co., Ltd.PTH2026-04-16
16936983144688Discover Multi-Drug 10 Drugs Rapid Test Cup (Urine)Hangzhou AllTest Biotech Co., Ltd.PTH2026-04-16
06936983114790Alltest Multi-Drug 15 Drugs Rapid Test Panel (Urine)-CLIA WaivedHangzhou AllTest Biotech Co., Ltd.PTH2026-04-16
06936983114806Alltest Multi-Drug 15 Drugs Rapid Test Cup (Urine)-CLIA WaivedHangzhou AllTest Biotech Co., Ltd.PTH2026-04-16
06936983114813Alltest Multi-Drug 15 Drugs Rapid Test Cup (Urine)-CLIA WaivedHangzhou AllTest Biotech Co., Ltd.PTH2026-04-16
06936983114820Alltest Multi-Drug 12 Drugs Rapid Test Cup (Urine)-CLIA WaivedHangzhou AllTest Biotech Co., Ltd.PTH2026-04-16
06936983114837Alltest Multi-Drug 12 Drugs Rapid Test Cup (Urine)-CLIA WaivedHangzhou AllTest Biotech Co., Ltd.PTH2026-04-16
06936983114844Alltest Multi-Drug 12 Drugs Rapid Test Cup (Urine)-CLIA WaivedHangzhou AllTest Biotech Co., Ltd.PTH2026-04-16