FDA.reportPublic FDA data

BioTeke

Primary DI
06974541566049
Brand
BioTeke
Company
Bioteke Corporation (Wuxi) Co., Ltd.
Model
1 Test/kit
Catalog number
ICA2506-14
Published
2026-10-13
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
true

Product Codes#

Code, Name table
CodeName
NFTTest, Amphetamine, Over The Counter
NFVTest, Benzodiazepine, Over The Counter
NFYTest, Cocaine And Cocaine Metabolites, Over The Counter
NGGTest, Methamphetamine, Over The Counter
NGLTest, Opiates, Over The Counter
NGMTest, Phencyclidine (Pcp), Over The Counter
PTGTest, Methadone, Over The Counter
PTHTest, Barbiturate, Over The Counter
QAWTest, Tricyclic Antidepressants, Over The Counter

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
NFTTest, Amphetamine, Over The CounterClinical Toxicology2
NFVTest, Benzodiazepine, Over The CounterClinical Toxicology2
NFYTest, Cocaine And Cocaine Metabolites, Over The CounterClinical Toxicology2
NGGTest, Methamphetamine, Over The CounterClinical Toxicology2
NGLTest, Opiates, Over The CounterClinical Toxicology2
NGMTest, Phencyclidine (Pcp), Over The CounterUnknownU
PTGTest, Methadone, Over The CounterClinical Toxicology2
PTHTest, Barbiturate, Over The CounterClinical Toxicology2
QAWTest, Tricyclic Antidepressants, Over The CounterClinical Toxicology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K261409000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K261409000BioTeke® Multi-Drug Urine Test CupBioteke Corporation (Wuxi) Co., Ltd.2026-09-10NFT

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
06974541566049PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
06974541566049069745415660496974541566049

GMDN Terms#

Term, Definition table
TermDefinition
Multiple drugs of abuse 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 multiple drugs of abuse 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
560011452
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
true
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
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
06974541564526BioTekeST9001-22025-01-09
06974541563031BioTeke ST7001-12023-02-14
06974541563048BioTeke ST7001-22023-02-14
06974541563086BioTeke ST8001-12023-02-16
06974541563109BioTeke ST8001-22023-02-16
06974541563116BioTeke ST8001-22023-02-16
06974541563147BioTeke ST9001-12023-02-16
06974541563154BioTeke ST9001-12023-02-16
06974541564069BioTekeST9001-22023-02-08
06974541564403BioTekeBTK-H2205BTK-H22052024-05-27
06974541564397BioTekeBTK-H2201BTK-H22012023-09-12
06974541564380BioTekeBTK-H2202BTK-H22022023-09-04
06974541563024BioTeke ST7001-12023-02-14
06974541563055BioTeke ST7001-22023-02-16
06974541563093BioTeke ST8001-12023-02-16
86974541564409BioTekeBTK-H2205BTK-H22052024-05-27
06974541564373biotekeST9001-22023-05-05
06974541564335BioTeke ST7001-12023-03-07
06974541564342BioTeke ST7001-12023-03-07
86974541564331BioTeke ST7001-12023-03-07

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
06942598249390One Step® Benzodiazepines (BZO300) Home Rapid Test DipstickHangzhou AllTest Biotech Co., Ltd.NFV2026-10-12
06942598249406One Step® Methamphetamine (MET500) Home Rapid Test DipstickHangzhou AllTest Biotech Co., Ltd.NGG2026-10-12
06942598249413One Step® Methadone (MTD300) Home Rapid Test DipstickHangzhou AllTest Biotech Co., Ltd.PTG2026-10-12
06942598249420One Step® Morphine (MOP/OPI2000) Home Rapid Test DipstickHangzhou AllTest Biotech Co., Ltd.NGL2026-10-12
06936983113939Alltest MDMA500 Rapid Test Panel (Urine)Hangzhou AllTest Biotech Co., Ltd.NGG2026-04-21
06936983113946Alltest MET500 Rapid Test Panel (Urine)Hangzhou AllTest Biotech Co., Ltd.NGG2026-04-21
06936983113953Alltest MOP300 Rapid Test Panel (Urine)Hangzhou AllTest Biotech Co., Ltd.NGL2026-04-21
06936983113960Alltest MTD300 Rapid Test Panel (Urine)Hangzhou AllTest Biotech Co., Ltd.PTG2026-04-21
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
06936983113991Alltest PCP25 Rapid Test Panel (Urine)Hangzhou AllTest Biotech Co., Ltd.NGM2026-04-21
06936983114004Alltest TCA1000 Rapid Test Panel (Urine)Hangzhou AllTest Biotech Co., Ltd.QAW2026-04-21
06936983114028Alltest AMP500 Rapid Test Dipstick (Urine)Hangzhou AllTest Biotech Co., Ltd.NFT2026-04-21
06936983114035Alltest BAR300 Rapid Test Dipstick (Urine)Hangzhou AllTest Biotech Co., Ltd.PTH2026-04-21
06936983114042Alltest BUP10 Rapid Test Dipstick (Urine)Hangzhou AllTest Biotech Co., Ltd.NGL2026-04-21
06936983114059Alltest BZO300 Rapid Test Dipstick (Urine)Hangzhou AllTest Biotech Co., Ltd.NFV2026-04-21
06936983114066Alltest COC150 Rapid Test Dipstick (Urine)Hangzhou AllTest Biotech Co., Ltd.NFY2026-04-21
06936983114073Alltest EDDP300 Rapid Test Dipstick (Urine)Hangzhou AllTest Biotech Co., Ltd.PTG2026-04-21
06936983114080Alltest MDMA500 Rapid Test Dipstick (Urine)Hangzhou AllTest Biotech Co., Ltd.NGG2026-04-21
06936983114097Alltest MET500 Rapid Test Dipstick (Urine)Hangzhou AllTest Biotech Co., Ltd.NGG2026-04-21
06936983114103Alltest MOP300 Rapid Test Dipstick (Urine)Hangzhou AllTest Biotech Co., Ltd.NGL2026-04-21
06936983114110Alltest MTD300 Rapid Test Dipstick (Urine)Hangzhou AllTest Biotech Co., Ltd.PTG2026-04-21
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
06936983114141Alltest PCP25 Rapid Test Dipstick (Urine)Hangzhou AllTest Biotech Co., Ltd.NGM2026-04-21
06936983114158Alltest TCA1000 Rapid Test Dipstick (Urine)Hangzhou AllTest Biotech Co., Ltd.QAW2026-04-21
06936983114172Alltest MDMA500 Rapid Test Dipstick(Urine)-CLIA WaivedHangzhou AllTest Biotech Co., Ltd.NGG2026-04-21
06936983114189Alltest BZO300 Rapid Test Dipstick(Urine)-CLIA WaivedHangzhou AllTest Biotech Co., Ltd.NFV2026-04-21
06936983114196Alltest AMP500 Rapid Test Dipstick (Urine)-CLIA WaivedHangzhou AllTest Biotech Co., Ltd.NFT2026-04-21