FDA.reportPublic FDA data

QuikScreen

Primary DI
00748349000243
Brand
QuikScreen
Company
SYNTRON BIORESEARCH, INC.
Model
60A42
Device description
QuikScreen Multi 10 Drug Cup Test - AMP 1000, BAR 300, BZD 300, COC 300, MAD 300, MET 1000, OPI 300, OXY 100, PCP 25, TCA 1000
Published
2016-12-13
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
DIOEnzyme Immunoassay, Cocaine And Cocaine Metabolites
DISEnzyme Immunoassay, Barbiturate
DJCThin Layer Chromatography, Methamphetamine
DJGEnzyme Immunoassay, Opiates
DJREnzyme Immunoassay, Methadone
DKZEnzyme Immunoassay, Amphetamine
JXMEnzyme Immunoassay, Benzodiazepine
LCMEnzyme Immunoassay, Phencyclidine
LFHU.V. Spectrometry, Tricyclic Antidepressant Drugs

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DIOEnzyme Immunoassay, Cocaine And Cocaine MetabolitesClinical Toxicology2
DISEnzyme Immunoassay, BarbiturateClinical Toxicology2
DJCThin Layer Chromatography, MethamphetamineClinical Toxicology2
DJGEnzyme Immunoassay, OpiatesClinical Toxicology2
DJREnzyme Immunoassay, MethadoneClinical Toxicology2
DKZEnzyme Immunoassay, AmphetamineClinical Toxicology2
JXMEnzyme Immunoassay, BenzodiazepineClinical Toxicology2
LCMEnzyme Immunoassay, PhencyclidineUnknownU
LFHU.V. Spectrometry, Tricyclic Antidepressant DrugsClinical Toxicology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K071489000
K130275000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K071489000HOMECHECK MULTIPLE DRUG CUP TESTTianjin New Bay Bioresearch Co., Ltd.2008-03-28DKZ
K130275000QUIKSCREEN MULTI (MDMA AND OPI) OTC DRUG CUP TESTTianjin New Bay Bioresearch Co., Ltd.2013-09-26DJG

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10748349000240PackageGS125In Commercial Distribution
20748349000247PackageGS14In Commercial Distribution
00748349000243PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1074834900024010748349000240
2074834900024720748349000247
00748349000243007483490002437483490002430748349000243

GMDN Terms#

Term, Definition table
TermDefinition
Drug/toxicology screen adulteration IVD, kit, rapid spectrophotometry, clinicalA collection of reagents and other associated materials intended to be used for the qualitative and/or (semi-)quantitative detection of drug and/or toxicology screen adulteration of a clinical specimen within a short period, relative to standard laboratory testing procedures, using a rapid spectrophotometry method. This is a rapid test commonly used in the laboratory or in point-of-care analyses. It is not intended to be used for self-testing.

Regulatory Flags#

DUNS number
174517060
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00748349000014QuikScreen 11+3 Drug Cup Test65B14-102016-09-24
00748349000038QuikScreen 13+4 Drug Cup Test65D03-172016-09-27
00748349000045QuikSreen 11 Drug Cup Test60B132016-09-27
00748349000052QuikScreen 5 Drug Cup Test605052016-09-27
00748349000069QuikStrip MultiDrug 4 Dip Card Test304A12016-09-29
00748349000090QuikStrip OneStep hCG9010-52016-09-30
00748349000106QuikScreen Multi 11 Drug Cup Test60B002016-10-04
00748349000113QuikScreen605102016-10-04
00748349000137QuikScreen607192016-10-19
00748349000151QuikScreen65C09-52016-10-19
00748349000168QuikScreen608252016-10-19
00748349000175QuikScreen Multi 12 Drug Cup Test60C092016-10-21
00748349000182QuikStrip MultiDrug X Screening Dip Card301212016-11-04
00748349000199QuikScreen 60B162016-11-04
00748349000205QuikScreen 4 Drug Cup604002016-11-11
00748349000229QuikScreen65917-192016-12-02
00748349000236QuikStrip90202016-12-09
00748349000274QuikScreen60C212017-02-24
00748349000281QuikScreen605542017-02-24
00748349000298QuikScreen65646-192017-02-24

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00810173656726HealgenHealgen Scientific Limited Liability CompanyDIO2026-06-03
00810173656726HealgenHealgen Scientific Limited Liability CompanyDJG2026-06-03
00810173656726HealgenHealgen Scientific Limited Liability CompanyJXM2026-06-03
00810173656726HealgenHealgen Scientific Limited Liability CompanyDIS2026-06-03
00810173656726HealgenHealgen Scientific Limited Liability CompanyLCM2026-06-03
00810173656726HealgenHealgen Scientific Limited Liability CompanyDJR2026-06-03
00810173656726HealgenHealgen Scientific Limited Liability CompanyDKZ2026-06-03
00810173656733HealgenHealgen Scientific Limited Liability CompanyJXM2026-06-03
00810173656733HealgenHealgen Scientific Limited Liability CompanyDJG2026-06-03
00810173656733HealgenHealgen Scientific Limited Liability CompanyLCM2026-06-03
00810173656733HealgenHealgen Scientific Limited Liability CompanyDJR2026-06-03
00810173656733HealgenHealgen Scientific Limited Liability CompanyDIS2026-06-03
00810173656733HealgenHealgen Scientific Limited Liability CompanyDIO2026-06-03
00810173656733HealgenHealgen Scientific Limited Liability CompanyDKZ2026-06-03
00810173656740HealgenHealgen Scientific Limited Liability CompanyDIO2026-06-03
00810173656740HealgenHealgen Scientific Limited Liability CompanyDJR2026-06-03
00810173656740HealgenHealgen Scientific Limited Liability CompanyLCM2026-06-03
00810173656740HealgenHealgen Scientific Limited Liability CompanyDIS2026-06-03
00810173656740HealgenHealgen Scientific Limited Liability CompanyJXM2026-06-03
00810173656740HealgenHealgen Scientific Limited Liability CompanyDJG2026-06-03
00810173656740HealgenHealgen Scientific Limited Liability CompanyDKZ2026-06-03
00810173656757HealgenHealgen Scientific Limited Liability CompanyDJR2026-06-03
00810173656757HealgenHealgen Scientific Limited Liability CompanyLCM2026-06-03
00810173656757HealgenHealgen Scientific Limited Liability CompanyDIS2026-06-03
00810173656757HealgenHealgen Scientific Limited Liability CompanyDKZ2026-06-03
00810173656757HealgenHealgen Scientific Limited Liability CompanyDIO2026-06-03
00810173656757HealgenHealgen Scientific Limited Liability CompanyDJG2026-06-03
00810173656757HealgenHealgen Scientific Limited Liability CompanyJXM2026-06-03
00810173656764HealgenHealgen Scientific Limited Liability CompanyDKZ2026-06-03
00810173656764HealgenHealgen Scientific Limited Liability CompanyDIO2026-06-03