FDA.reportPublic FDA data

Benzodiazepines Panel Dip

Primary DI
06952804801816
Brand
Benzodiazepines Panel Dip
Company
ASSURE TECH. (HANGZHOU) CO., LTD.
Model
1.0
Published
2017-07-25
Public version status
Update
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
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
K170049000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K170049000AssureTech Panel Dip Test, AssureTech Quick Cup TestAssure Tech. (Hangzhou) Co, Ltd.2017-05-02NFT

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
06952804801816PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
06952804801816069528048018166952804801816

GMDN Terms#

Term, Definition table
TermDefinition
Benzodiazepine group IVD, kit, immunochromatographic test (ICT), rapidA collection of reagents and other associated materials intended to be used for the qualitative and/or semi-quantitative detection of benzodiazepine in a clinical specimen within a short period relative to standard laboratory testing procedures, using an immunochromatographic test (ICT) method. This test is commonly used in the laboratory or in point-of-care analyses.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
530757741
Device count
1
Lot or batch
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
26952804809700Multi-dip Drugs Test (BZO 300 Dip Card)1.02026-02-10
16952804808324Multi-Panel Drug Test Cup1.02025-03-18
06952804802608AssureTech Panel Dip Tests1.02018-09-04
06952804802615AssureTech Quick Cup Tests1.02018-09-04
06952804802622AssureTech Panel Dip Tests1.02018-09-04
06952804802639AssureTech Quick Cup Tests1.02018-09-04
26952804810461Marijuana Test Strip1.02025-03-18
06952804801175Methamphetamine Strip1.02017-02-06
06952804801182Phencyclidine Strip1.02017-02-06
06952804801199Marijuana Strip1.02017-02-06
06952804801458Methamphetamine/Phencyclidine/Marijuana Panel Dip1.02017-02-07
06952804801465Methamphetamine/Phencyclidine/Marijuana Quick Cup1.02017-02-07
06952804801472Methamphetamine/Phencyclidine/Marijuana Turnkey Split Cup1.02017-02-07
06952804801779Methamphetamine Panel Dip1.02017-07-24
06952804801786Phencyclidine Panel Dip1.02017-07-24
06952804801793Marijuana Panel Dip1.02017-07-24
06952804801090hCG Pregnancy Test Cassette1.02016-09-24
06952804801205hCG Pregnancy Serum/Urine Combo Test Cassette1.0HCG-C232017-02-04
06952804801212HCG Pregnancy Test Strip1.02016-09-24
06952804801830hCG Pregnancy Serum/Urine Combo Test Strip(10/20)1.02017-07-25

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
06937339211507BioSieveVivachek Biotech (Hangzhou) Co., Ltd.NFV2026-10-14
06937339211538BioSieveVivachek Biotech (Hangzhou) Co., Ltd.NFV2026-10-14
06974541566049BioTekeBioteke Corporation (Wuxi) Co., Ltd.NFV2026-10-13
06942598249390One Step® Benzodiazepines (BZO300) Home Rapid Test DipstickHangzhou AllTest Biotech Co., Ltd.NFV2026-10-12
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
06936983114844Alltest Multi-Drug 12 Drugs Rapid Test Cup (Urine)-CLIA WaivedHangzhou AllTest Biotech Co., Ltd.NFV2026-04-16
06936983114868Alltest Multi-Drug 15 Drugs Rapid Test Cup (Urine)Hangzhou AllTest Biotech Co., Ltd.NFV2026-04-16