QuikScreen

Primary DI
20748349000117
Brand
QuikScreen
Company
SYNTRON BIORESEARCH, INC.
Model
60510
Device description
QuikScreen Multi 5 Drug Cup Test - AMP 1000, BZD 300, COC 300, OPI 2000, THC 50
Published
2016-10-04
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
true

Product Codes#

Code, Name table
CodeName
LFHU.V. Spectrometry, Tricyclic Antidepressant Drugs

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LFHU.V. Spectrometry, Tricyclic Antidepressant DrugsClinical Toxicology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K071489000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K071489000HOMECHECK MULTIPLE DRUG CUP TESTTianjin New Bay Bioresearch Co., Ltd.2008-03-28DKZ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10748349000110PackageGS125In Commercial Distribution
20748349000117PackageGS14In Commercial Distribution
00748349000113PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1074834900011010748349000110
2074834900011720748349000117
00748349000113007483490001137483490001130748349000113

GMDN Terms#

Term, Definition table
TermDefinition
Drug/toxicology adulteration IVD, kit, enzyme spectrophotometry, rapidA collection of reagents and other associated materials intended to be used for the qualitative detection of drug and/or toxicology adulteration of a clinical specimen within a short period relative to standard laboratory testing procedures, using an enzyme spectrophotometry method. This test is commonly used in the laboratory or in point-of-care analyses.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
174517060
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
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
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
00748349000243QuikScreen60A422016-12-13
00748349000274QuikScreen60C212017-02-24
00748349000281QuikScreen605542017-02-24

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00630414595849TD TRICYC ANTIDEPRESSANT ASSAY, TCASiemens Healthcare Diagnostics Inc.LFH2018-12-01
00868348000256Status Toxi CupLifesign L.L.C.LFH2017-05-17
10868348000253Status Toxi CupLifesign L.L.C.LFH2017-05-17
00816565020960Fastect II Drug Screen Dipstick TestAMEDITECH INC.LFH2017-03-31
00748349000311QuikScreenSYNTRON BIORESEARCH, INC.LFH2017-02-27
00748349000274QuikScreenSYNTRON BIORESEARCH, INC.LFH2017-02-24
00748349000243QuikScreenSYNTRON BIORESEARCH, INC.LFH2016-12-13
00748349000199QuikScreen SYNTRON BIORESEARCH, INC.LFH2016-11-04
20748349000193QuikScreen SYNTRON BIORESEARCH, INC.LFH2016-11-04
00748349000175QuikScreen Multi 12 Drug Cup TestSYNTRON BIORESEARCH, INC.LFH2016-10-21
20748349000179QuikScreen Multi 12 Drug Cup TestSYNTRON BIORESEARCH, INC.LFH2016-10-21
00748349000106QuikScreen Multi 11 Drug Cup TestSYNTRON BIORESEARCH, INC.LFH2016-10-04
00748349000113QuikScreenSYNTRON BIORESEARCH, INC.LFH2016-10-04
10864040000331QTEST 11 (25 pack)MEDIMPEX UNITED, INCLFH2016-09-30
10864040000348QTEST 12 (25 Pack)MEDIMPEX UNITED, INCLFH2016-09-30
00863480002106LifeSign QuikScreen 11Lifesign L.L.C.LFH2016-09-24
00863480002113Status Toxi Cup 13+4Lifesign L.L.C.LFH2016-09-24
00842768001277Syva® RapidTest d.a.u.® TCASiemens Healthcare Diagnostics Inc.LFH2016-09-24
20863480002117Status Toxi Cup 13+4Lifesign L.L.C.LFH2016-09-24
00630414551036ADVIA® Chemistry TCASiemens Healthcare Diagnostics Inc.LFH2016-09-24
10763924086532ACCUTEST - 5 Drug Test Cup *CLIA-Waived*JANT PHARMACAL CORPORATIONLFH2016-09-23
10763924087539ACCUTEST - 6 Drug CupJANT PHARMACAL CORPORATIONLFH2016-09-23
10763924811530ACCUTEST Drug Test Cup 11-Panel CLIA-WaivedJANT PHARMACAL CORPORATIONLFH2016-09-23
10763924822536ACCUTEST Drug Test Cup 12-Panel CLIA-WaivedJANT PHARMACAL CORPORATIONLFH2016-09-23
10763924823533ACCUTEST Drug Test Cup 13-Panel CLIA-WaivedJANT PHARMACAL CORPORATIONLFH2016-09-23
00817405020010Alere iCup Dx 14Instant Technologies, Inc.LFH2016-09-19
00817405020027Alere iCup Dx 14Instant Technologies, Inc.LFH2016-09-19
00817405020126Alere iScreen DxInstant Technologies, Inc.LFH2016-09-19
00817405020171Alere iScreen DxInstant Technologies, Inc.LFH2016-09-19
00884883001183DRI Tricyclics Serum Tox AssayMicrogenics CorporationLFH2016-09-12