FDA.reportPublic FDA data

AssureTech Panel Dip Tests

Primary DI
06952804830212
Brand
AssureTech Panel Dip Tests
Company
ASSURE TECH. (HANGZHOU) CO., LTD.
Model
1.0
Device description
AMP500, THC50, COC150, MET500, MOR300, BZO300, OXY100, BAR300, BUP10, MDMA500, PCP25, MTD300, EDDP300, TCA1000, PPX300
Published
2018-09-05
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
NFVTest, Benzodiazepine, Over The Counter
NFWTest, Cannabinoid, 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
QBFTest, Propoxyphene, Over The Counter

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
NFVTest, Benzodiazepine, Over The CounterClinical Toxicology2
NFWTest, Cannabinoid, 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
QBFTest, Propoxyphene, Over The CounterClinical Toxicology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K181768000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K181768000AssureTech Panel Dip Tests, AssureTech Quick Cup TestsAssure Tech. (Hangzhou) Co, Ltd.2018-08-20NFT

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
06952804830212PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
06952804830212069528048302126952804830212

GMDN Terms#

Term, Definition table
TermDefinition
Multiple drugs of abuse 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 one or multiple drugs of abuse 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
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
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
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
10722066015053Rapid ResponseBTNX IncQAW2026-05-15
10722066015053Rapid ResponseBTNX IncNFV2026-05-15
10722066015053Rapid ResponseBTNX IncNFY2026-05-15
10722066015053Rapid ResponseBTNX IncPTH2026-05-15
10722066015053Rapid ResponseBTNX IncNGG2026-05-15
10722066015053Rapid ResponseBTNX IncPTG2026-05-15
10722066015053Rapid ResponseBTNX IncNGM2026-05-15
10722066015053Rapid ResponseBTNX IncNFW2026-05-15
10722066015053Rapid ResponseBTNX IncNGL2026-05-15
10722066015053Rapid ResponseBTNX IncQBF2026-05-15
10722066015084Rapid ResponseBTNX IncQAW2026-05-15
10722066015084Rapid ResponseBTNX IncPTH2026-05-15
10722066015084Rapid ResponseBTNX IncNGG2026-05-15
10722066015084Rapid ResponseBTNX IncPTG2026-05-15
10722066015084Rapid ResponseBTNX IncQBF2026-05-15
10722066015084Rapid ResponseBTNX IncNGM2026-05-15
10722066015084Rapid ResponseBTNX IncNGL2026-05-15
10648564316280SnapCheckDx Rapid Urine THC TestHangzhou Aichek Medical Technology Co., Ltd.NFW2026-05-12
10722066011260Rapid ResponseBTNX IncNGL2026-01-19
10722066011260Rapid ResponseBTNX IncNGG2026-01-19
10722066011260Rapid ResponseBTNX IncNFV2026-01-19
10722066011260Rapid ResponseBTNX IncNFY2026-01-19
10722066011260Rapid ResponseBTNX IncNFW2026-01-19
10722066011260Rapid ResponseBTNX IncPTG2026-01-19
10722066011260Rapid ResponseBTNX IncPTH2026-01-19
10722066011260Rapid ResponseBTNX IncNGM2026-01-19
10722066011260Rapid ResponseBTNX IncQBF2026-01-19
10722066011260Rapid ResponseBTNX IncQAW2026-01-19
10722066011277Rapid ResponseBTNX IncQBF2026-01-19
10722066011277Rapid ResponseBTNX IncNFV2026-01-19