FDA.reportPublic FDA data

One Step® Benzodiazepines (BZO300) Home Rapid Test Dipstick

Primary DI
06942598249390
Brand
One Step® Benzodiazepines (BZO300) Home Rapid Test Dipstick
Company
Hangzhou AllTest Biotech Co., Ltd.
Model
1
Catalog number
DBZ-A101H
Device description
5T/kit, EN&.ES, non-CE
Published
2026-10-12
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
NFVTest, Benzodiazepine, Over The Counter

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
NFVTest, Benzodiazepine, 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
06942598249390PrimaryGS10
86942598249396Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
06942598249390069425982493906942598249390
8694259824939686942598249396

Regulatory Flags#

DUNS number
543254717
Device count
5
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
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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06978151200287Pocguide Multi-Drug Test Panel OTCHangzhou Aichek Medical Technology Co., Ltd.NFV2026-10-27
06978151200294Pocguide Multi-Drug Test Cup OTCHangzhou Aichek Medical Technology Co., Ltd.NFV2026-10-27
06937339211507BioSieveVivachek Biotech (Hangzhou) Co., Ltd.NFV2026-10-14
06937339211538BioSieveVivachek Biotech (Hangzhou) Co., Ltd.NFV2026-10-14
06974541566049BioTekeBioteke Corporation (Wuxi) Co., Ltd.NFV2026-10-13
10722066005511Rapid ResponseBTNX IncNFV2026-10-09
10722066018979Rapid ResponseBTNX IncNFV2026-10-08
10722066019013Rapid ResponseBTNX IncNFV2026-10-08
10722066019020Rapid ResponseBTNX IncNFV2026-10-08
10722066019037Rapid ResponseBTNX IncNFV2026-10-08
10722066019044Rapid ResponseBTNX IncNFV2026-10-08
10722066018955Rapid ResponseBTNX IncNFV2026-10-06
10722066018696Rapid ResponseBTNX IncNFV2026-09-18
06936983114059Alltest BZO300 Rapid Test Dipstick (Urine)Hangzhou AllTest Biotech Co., Ltd.NFV2026-04-21
06936983114189Alltest BZO300 Rapid Test Dipstick(Urine)-CLIA WaivedHangzhou AllTest Biotech Co., Ltd.NFV2026-04-21
06936983114349Alltest BZO300 Rapid Test Panel (Urine)-CLIA WaivedHangzhou AllTest Biotech Co., Ltd.NFV2026-04-21
06936983114578Alltest BZO300 Home Rapid Test Dipstick (Urine)Hangzhou AllTest Biotech Co., Ltd.NFV2026-04-21
06936983113908Alltest BZO300 Rapid Test Panel (Urine)Hangzhou AllTest Biotech Co., Ltd.NFV2026-04-17
16936983131633Multi-Drug Rapid Test Panel (Urine)Hangzhou AllTest Biotech Co., Ltd.NFV2026-04-16
16936983131640Multi-Drug Rapid Test Panel (Urine)Hangzhou AllTest Biotech Co., Ltd.NFV2026-04-16
16936983138632Multi-Drug 12 Drugs Rapid Test CupHangzhou AllTest Biotech Co., Ltd.NFV2026-04-16
16936983141120Discover Multi-Drug 12 Drugs Rapid Test CupHangzhou AllTest Biotech Co., Ltd.NFV2026-04-16
16936983141137Discover Multi-Drug 12 Drugs Rapid Test CupHangzhou AllTest Biotech Co., Ltd.NFV2026-04-16
16936983144688Discover Multi-Drug 10 Drugs Rapid Test Cup (Urine)Hangzhou AllTest Biotech Co., Ltd.NFV2026-04-16
06936983114790Alltest Multi-Drug 15 Drugs Rapid Test Panel (Urine)-CLIA WaivedHangzhou AllTest Biotech Co., Ltd.NFV2026-04-16
06936983114806Alltest Multi-Drug 15 Drugs Rapid Test Cup (Urine)-CLIA WaivedHangzhou AllTest Biotech Co., Ltd.NFV2026-04-16
06936983114813Alltest Multi-Drug 15 Drugs Rapid Test Cup (Urine)-CLIA WaivedHangzhou AllTest Biotech Co., Ltd.NFV2026-04-16
06936983114820Alltest Multi-Drug 12 Drugs Rapid Test Cup (Urine)-CLIA WaivedHangzhou AllTest Biotech Co., Ltd.NFV2026-04-16
06936983114837Alltest Multi-Drug 12 Drugs Rapid Test Cup (Urine)-CLIA WaivedHangzhou AllTest Biotech Co., Ltd.NFV2026-04-16