FDA.reportPublic FDA data

QuikStrip MultiDrug X Screening Dip Card

Primary DI
00748349000182
Brand
QuikStrip MultiDrug X Screening Dip Card
Company
SYNTRON BIORESEARCH, INC.
Model
30121
Device description
QuikStrip Multidrug 1 Screening Dip Card Test - MAD 300 ng/ml
Published
2016-11-04
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
DJREnzyme Immunoassay, Methadone

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DJREnzyme Immunoassay, MethadoneClinical Toxicology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K061617000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K061617000FORSURE ONE STEP DIP & READ (X) DRUG SCREEN TESTTianjin New Bay Bioresearch Co., Ltd.2006-11-22DKZ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10748349000189PackageGS125In Commercial Distribution
00748349000182PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1074834900018910748349000189
00748349000182007483490001827483490001820748349000182

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
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
00748349000298QuikScreen65646-192017-02-24

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Primary DI, Brand, Company table
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00810173656764HealgenHealgen Scientific Limited Liability CompanyDJR2026-06-03
00810173656771HealgenHealgen Scientific Limited Liability CompanyDJR2026-06-03
00810173656788HealgenHealgen Scientific Limited Liability CompanyDJR2026-06-03
00810173656702AccurateHealgen Scientific Limited Liability CompanyDJR2026-06-02
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