FDA.reportPublic FDA data

MEDTOXScan® Reader

Primary DI
00690286000063
Brand
MEDTOXScan® Reader
Company
MEDTOX DIAGNOSTICS, INC.
Model
833073
Device description
An instrument used to interpret and report the results of the PROFILE®-V MEDTOXScan® Test Devices, which are one-step immunochromatographic tests for the rapid, qualitative detection of one or more drugs in human urine.
Published
2016-09-24
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
JJQColorimeter, Photometer, Spectrophotometer For Clinical Use

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
JJQColorimeter, Photometer, Spectrophotometer For Clinical UseClinical Chemistry1

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K080635000
K091454000
K100023000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K080635000MEDTOXSCANMedtox Diagnostics, Inc.2009-02-13DKZ
K091454000PROFILE-V MEDTOXSCAN DRUGS OF ABUSE TEST SYSTEMMedtox Diagnostics, Inc.2009-07-24DJG
K100023000PROFILE-V MEDTOXSCAN DRUGS OF ABUSE TEST SYSTEM AND 12 DRUGS TEST SYSTEMMedtox Diagnostics, Inc.2010-04-05DJG

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00690286000063PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00690286000063006902860000636902860000630690286000063

GMDN Terms#

Term, Definition table
TermDefinition
Multiplex analyser IVD, laboratory, semi-automatedA mains electricity (AC-powered) laboratory instrument intended to be used for the qualitative and/or quantitative simultaneous determination of multiple chemical and/or biological markers in a single clinical specimen using an immunological method which incorporates multiple antibodies arranged on a solid surface (e.g., slide, plate, membrane) or coated to micro-particles. It typically includes a system for the detection of bound target antigen (e.g., chemiluminescent, fluorescent, photometric, magnetic detector), together with sample processing, data processing and data display software. It operates with reduced technician involvement and automation of some, but not all, procedural steps.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
877-643-5703techservices@medtoxdiagnostics.com

Regulatory Flags#

DUNS number
137417965
Device count
1
Serial number
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00850024924109Labcorp Comfort Draw20000003512026-05-22
00690286000742MEDTOX®1025202026-03-31
00690286000797Labcorp Fentanyl Urine Visual Test6060002026-03-31
00860001286564TrueSpinS0012024-12-13
00862105000398TrakTZZ-0-1C2022-07-05
00860001286502TrakTTK-0-3 Rev 32021-06-23
00690286000759PROFILE®-V MEDTOXScan®6040312023-08-01
00690286000766PROFILE®-V MEDTOXScan®6040322023-08-01
10690286000756PROFILE®-V MEDTOXScan®6040312023-08-01
10690286000763PROFILE®-V MEDTOXScan®6040322023-08-01
00690286000551MEDTOX® 1011832016-09-24
00690286000568PROFILE®-V MEDTOXScan®1023652016-09-24
00690286000575PROFILE®-V MEDTOXScan®1023672016-09-24
00690286000773PROFILE®-IIA6016832023-06-01
10690286000770PROFILE®-IIA6016832023-06-01
00690286000780PROFILE-II ER®6016842023-06-01
00860001286533Men's Rapid Fertility TestTQK-0-12022-07-26
00862105000305Men's Rapid Fertility TestTTK-0-3 Rev 42022-06-13
00862105000312Men's Rapid Fertility TestTRK-0-1 Rev 42022-06-13
00860001286519TrakTTK-0-1 Rev 22021-06-23

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Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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00850049545501Diagnostic Automation, Inc.Diagnostic Automation, Inc.JJQ2025-12-24
00860011967750ZELLECHEM 200STERILE SAFEQUIP & CHEMICALS LLPJJQ2024-10-01
00816467020396FastPack® IP SystemQUALIGEN INC.JJQ2024-09-27
00816467020402FastPack® IP SystemQUALIGEN INC.JJQ2024-09-27
00816870020006NeoLumax CLIA AnalyzerMONOBIND, INC.JJQ2024-09-13
00816870020013LuMatic CLIA AnalyzerMONOBIND, INC.JJQ2024-09-13
00816870020051NeoEldex ELISA AnalyzerMONOBIND, INC.JJQ2024-09-13
00816870020068PrisMatic ELISA AnalyzerMONOBIND, INC.JJQ2024-09-13
00816870020075Autoplex G1 ELISA AnalyzerMONOBIND, INC.JJQ2024-09-13
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00816870024448Autoplex G3 ELISA + CLIA AnalyzerMONOBIND, INC.JJQ2024-09-13
07290016923063Auto Sampler (for BreathID Hp Lab System)MERIDIAN BIOSCIENCE ISRAEL LTDJJQ2024-07-22
07290016923384BreathID Hp Lab DeviceMERIDIAN BIOSCIENCE ISRAEL LTDJJQ2024-07-22
07290016923391BreathID Hp Lab Device (WIN)MERIDIAN BIOSCIENCE ISRAEL LTDJJQ2024-07-22
00860011967743ZELLECHEM-PROSTERILE SAFEQUIP & CHEMICALS LLPJJQ2024-07-09
04048474052527DRG:HYBRiD.XL®DRG Instruments Gesellschaft mit beschränkter HaftungJJQ2023-09-02
00840239052520DRG:HYBRiD.XL®DRG International IncJJQ2023-08-26
10810138822705EndocatorEndo Direct LLCJJQ2023-07-16
09120052071184SUNRISETecan Austria GmbHJJQ2023-07-06
09120052071191SUNRISE-RC/ST EVOLYZERTecan Austria GmbHJJQ2023-07-06
09120052071207SUNRISE-RC/TW EVOLYZERTecan Austria GmbHJJQ2023-07-06
09120052071214SUNRISE-RC/6F EVOLYZERTecan Austria GmbHJJQ2023-07-06
06936895300151BIOBASEBiobase Biodustry(Shandong)Co., Ltd.JJQ2023-07-04
06936895300212BIOBASEBiobase Biodustry(Shandong)Co., Ltd.JJQ2023-07-04
06936895300229BIOBASEBiobase Biodustry(Shandong)Co., Ltd.JJQ2023-07-04
06936895300236BIOBASEBiobase Biodustry(Shandong)Co., Ltd.JJQ2023-07-04
06936895300243BIOBASEBiobase Biodustry(Shandong)Co., Ltd.JJQ2023-07-04
00850229007010StatFaxAWARENESS TECHNOLOGY, INCORPORATEDJJQ2023-06-05