FDA.reportPublic FDA data

QuikStrip MultiDrug X Screening Dip Card

Primary DI
10748349000189
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
Rx
false
OTC
false
Sterile
false
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 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

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Primary DI, Brand, Company table
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00810173656740HealgenHealgen Scientific Limited Liability CompanyDJR2026-06-03
00810173656757HealgenHealgen Scientific Limited Liability CompanyDJR2026-06-03
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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10850013035554Identify®Diagnostics Drug Test DipMEDICAL DISTRIBUTION GROUP INCDJR2026-05-28
10850013035561Identify HealthMEDICAL DISTRIBUTION GROUP INCDJR2026-05-28
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10850013035684Identify®Diagnostics Drug Test CupsMEDICAL DISTRIBUTION GROUP INCDJR2026-05-28
10850013035707Identify®Diagnostics Drug Test CupsMEDICAL DISTRIBUTION GROUP INCDJR2026-05-28
10694644400745INCUPAMERICAN BIO MEDICA CORPORATIONDJR2021-06-24
10612479255293McKessonMCKESSON MEDICAL-SURGICAL INC.DJR2020-06-18
10612479255323McKessonMCKESSON MEDICAL-SURGICAL INC.DJR2020-06-18
10694644100454Rapid TOXAMERICAN BIO MEDICA CORPORATIONDJR2020-05-29
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10694644400714INCUPAMERICAN BIO MEDICA CORPORATIONDJR2019-03-11
10694644100447Rapid TOXAMERICAN BIO MEDICA CORPORATIONDJR2019-02-12
10694644400707INCUPAMERICAN BIO MEDICA CORPORATIONDJR2018-10-29
10694644200482RTCII 1st gen.AMERICAN BIO MEDICA CORPORATIONDJR2018-05-23
10694644400691INCUPAMERICAN BIO MEDICA CORPORATIONDJR2018-04-20
10694644200475RTCII 1st gen.AMERICAN BIO MEDICA CORPORATIONDJR2018-04-19
10694644100430Rapid TOXAMERICAN BIO MEDICA CORPORATIONDJR2018-03-30