FDA.reportPublic FDA data

Alltest BUP10 Rapid Test Panel (Urine)-CLIA Waived

Primary DI
06936983114462
Brand
Alltest BUP10 Rapid Test Panel (Urine)-CLIA Waived
Company
Hangzhou AllTest Biotech Co., Ltd.
Model
1
Catalog number
DBU-A114C (10ng)
Device description
25T, for FDA CLIA Waived
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
true
Sterile
false
Single use
true

Product Codes#

Code, Name table
CodeName
NGLTest, Opiates, Over The Counter

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
NGLTest, Opiates, 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
06936983114462PrimaryGS10
86936983114468Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
06936983114462069369831144626936983114462
8693698311446886936983114468

GMDN Terms#

Term, Definition table
TermDefinition
Buprenorphine 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 buprenorphine 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
06942598249383One Step® Buprenorphine (BUP10) Home Rapid Test DipstickHangzhou AllTest Biotech Co., Ltd.NGL2026-10-12
06942598249420One Step® Morphine (MOP/OPI2000) Home Rapid Test DipstickHangzhou AllTest Biotech Co., Ltd.NGL2026-10-12
10722066005511Rapid ResponseBTNX IncNGL2026-10-09
10722066018979Rapid ResponseBTNX IncNGL2026-10-08
10722066019013Rapid ResponseBTNX IncNGL2026-10-08
10722066019020Rapid ResponseBTNX IncNGL2026-10-08
10722066019037Rapid ResponseBTNX IncNGL2026-10-08
10722066019044Rapid ResponseBTNX IncNGL2026-10-08
10722066018955Rapid ResponseBTNX IncNGL2026-10-06
10722066018696Rapid ResponseBTNX IncNGL2026-09-18
G474M210501EI0mLife Rapid Drug TestMlife Diagnostics, LLCNGL2026-08-14
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
06936983114042Alltest BUP10 Rapid Test Dipstick (Urine)Hangzhou AllTest Biotech Co., Ltd.NGL2026-04-21
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
06936983114202Alltest BUP10 Rapid Test Dipstick (Urine)-CLIA WaivedHangzhou AllTest Biotech Co., Ltd.NGL2026-04-21
06936983114226Alltest OXY100 Rapid Test Dipstick (Urine)-CLIA WaivedHangzhou AllTest Biotech Co., Ltd.NGL2026-04-21
06936983114240Alltest MOP300 Rapid Test Dipstick (Urine)-CLIA WaivedHangzhou AllTest Biotech Co., Ltd.NGL2026-04-21
06936983114301Alltest MOP2000 Rapid Test Dipstick (Urine)-CLIA WaivedHangzhou AllTest Biotech Co., Ltd.NGL2026-04-21
06936983114325Alltest MOP300 Rapid Test Dipstick (Urine)-CLIA WaivedHangzhou AllTest Biotech Co., Ltd.NGL2026-04-21
06936983114400Alltest MOP2000 Rapid Test Panel (Urine)-CLIA WaivedHangzhou AllTest Biotech Co., Ltd.NGL2026-04-21
06936983114417Alltest OXY100 Rapid Test Panel (Urine)-CLIA WaivedHangzhou AllTest Biotech Co., Ltd.NGL2026-04-21
06936983114486Alltest OXY100 Home Rapid Test Dipstick (Urine)Hangzhou AllTest Biotech Co., Ltd.NGL2026-04-21
06936983114561Alltest BUP10 Home Rapid Test Dipstick (Urine)Hangzhou AllTest Biotech Co., Ltd.NGL2026-04-21
06936983114615Alltest MOP300 Home Rapid Test Dipstick (Urine)Hangzhou AllTest Biotech Co., Ltd.NGL2026-04-21
06936983114639Alltest OXY100 Home Rapid Test Panel (Urine)Hangzhou AllTest Biotech Co., Ltd.NGL2026-04-21
06936983114714Alltest BUP10 Home Rapid Test Panel (Urine)Hangzhou AllTest Biotech Co., Ltd.NGL2026-04-21