FDA.reportPublic FDA data

OPI/COC/THC Tests Panel

Primary DI
06952804801946
Brand
OPI/COC/THC Tests Panel
Company
ASSURE TECH. (HANGZHOU) CO., LTD.
Model
1.0
Published
2017-08-18
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Single use
true

Product Codes#

Code, Name table
CodeName
NFWTest, Cannabinoid, Over The Counter
NFYTest, Cocaine And Cocaine Metabolites, Over The Counter
NGLTest, Opiates, Over The Counter

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
NFWTest, Cannabinoid, Over The CounterClinical Toxicology2
NFYTest, Cocaine And Cocaine Metabolites, Over The CounterClinical Toxicology2
NGLTest, Opiates, 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
06952804801946PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
06952804801946069528048019466952804801946

GMDN Terms#

Term, Definition table
TermDefinition
Cocaine/cocaine metabolite 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 cocaine and/or cocaine metabolites 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
00311917077932WalgreensWALGREEN CO.NGL2026-10-14
00311917077932WalgreensWALGREEN CO.NFY2026-10-14
00311917077932WalgreensWALGREEN CO.NFW2026-10-14
06937339211507BioSieveVivachek Biotech (Hangzhou) Co., Ltd.NFW2026-10-14
06937339211507BioSieveVivachek Biotech (Hangzhou) Co., Ltd.NFY2026-10-14
06937339211507BioSieveVivachek Biotech (Hangzhou) Co., Ltd.NGL2026-10-14
06937339211538BioSieveVivachek Biotech (Hangzhou) Co., Ltd.NFW2026-10-14
06937339211538BioSieveVivachek Biotech (Hangzhou) Co., Ltd.NFY2026-10-14
06937339211538BioSieveVivachek Biotech (Hangzhou) Co., Ltd.NGL2026-10-14
06974541566049BioTekeBioteke Corporation (Wuxi) Co., Ltd.NFY2026-10-13
06974541566049BioTekeBioteke Corporation (Wuxi) Co., Ltd.NGL2026-10-13
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 IncNFW2026-10-09
10722066005511Rapid ResponseBTNX IncNFY2026-10-09
10722066005511Rapid ResponseBTNX IncNGL2026-10-09
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
06936983114011Alltest THC50 Rapid Test Panel (Urine)Hangzhou AllTest Biotech Co., Ltd.NFW2026-04-21
06936983114042Alltest BUP10 Rapid Test Dipstick (Urine)Hangzhou AllTest Biotech Co., Ltd.NGL2026-04-21
06936983114066Alltest COC150 Rapid Test Dipstick (Urine)Hangzhou AllTest Biotech Co., Ltd.NFY2026-04-21
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
06936983114165Alltest THC50 Rapid Test Dipstick (Urine)Hangzhou AllTest Biotech Co., Ltd.NFW2026-04-21
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
06936983114264Alltest THC50 Rapid Test Dipstick (Urine)-CLIA WaivedHangzhou AllTest Biotech Co., Ltd.NFW2026-04-21