FDA.reportPublic FDA data

MEDTOXScan®

Primary DI
00690286000094
Brand
MEDTOXScan®
Company
MEDTOX DIAGNOSTICS, INC.
Model
833077
Device description
A micro pipette designed to dispense an accurate volume of sample for the PROFILE®-V MEDTOXScan® Test Devices.
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
JRCMicro Pipette

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
JRCMicro PipetteClinical 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
00690286000094PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00690286000094006902860000946902860000940690286000094

GMDN Terms#

Term, Definition table
TermDefinition
Mechanical pipetteA manually-operated device typically used in the laboratory to withdraw, transfer, and inject discrete volumes of fluid materials. The device is typically hand-held and operates through an internal mechanism powered by the fingers; it can have a single channel or multichannel piston/cylinder pick-up assembly. The device transfers consistent volumes of liquid into one or several receptacles simultaneously (e.g., the wells of a microtitre plate). A pipette may be factory pre-set to deliver a given volume, or may have user-selectable volumes within a useful volume range. The delivered volume may be mechanically indicated.

Sterilization Methods#

Method table
Method

Contacts#

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

Regulatory Flags#

DUNS number
137417965
Device count
1
Lot or batch
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00875197007459cobas® Liat Transfer Pipette PackRoche Molecular Systems, Inc.JRC2026-03-26
10810050855799SmearsafeTYPENEX MEDICAL LLCJRC2025-10-13
04038917085830Haemo-Diff®Sarstedt Aktiengesellschaft & Co.KGJRC2025-09-25
00840095688840Globe Scientific GLOBE SCIENTIFIC INC.JRC2025-07-07
00840095688857Globe Scientific GLOBE SCIENTIFIC INC.JRC2025-07-07
00840095688864Globe Scientific GLOBE SCIENTIFIC INC.JRC2025-07-07
00840095688871Globe Scientific GLOBE SCIENTIFIC INC.JRC2025-07-07
00840095688888Globe Scientific GLOBE SCIENTIFIC INC.JRC2025-07-07
00840095688895Globe Scientific GLOBE SCIENTIFIC INC.JRC2025-07-07
00840095688901Globe Scientific GLOBE SCIENTIFIC INC.JRC2025-07-07
00840095688918Globe Scientific GLOBE SCIENTIFIC INC.JRC2025-07-07
00840095688925Globe Scientific GLOBE SCIENTIFIC INC.JRC2025-07-07
00840095688932Globe Scientific GLOBE SCIENTIFIC INC.JRC2025-07-07
00840095688949Globe Scientific GLOBE SCIENTIFIC INC.JRC2025-07-07
00840095688956Globe Scientific GLOBE SCIENTIFIC INC.JRC2025-07-07
00840095688994Globe Scientific GLOBE SCIENTIFIC INC.JRC2025-07-07
00840095689007Globe Scientific GLOBE SCIENTIFIC INC.JRC2025-07-07
00840095689014Globe Scientific GLOBE SCIENTIFIC INC.JRC2025-07-07
00840095689021Globe Scientific GLOBE SCIENTIFIC INC.JRC2025-07-07
00840095689038Globe Scientific GLOBE SCIENTIFIC INC.JRC2025-07-07
00840095689045Globe Scientific GLOBE SCIENTIFIC INC.JRC2025-07-07
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00840095689069Globe Scientific GLOBE SCIENTIFIC INC.JRC2025-07-07
00840095689076Globe Scientific GLOBE SCIENTIFIC INC.JRC2025-07-07
00840095689083Globe Scientific GLOBE SCIENTIFIC INC.JRC2025-07-07
00840095689090Globe Scientific GLOBE SCIENTIFIC INC.JRC2025-07-07
00840095689106Globe Scientific GLOBE SCIENTIFIC INC.JRC2025-07-07
00840095689113Globe Scientific GLOBE SCIENTIFIC INC.JRC2025-07-07
00840095689120Globe Scientific GLOBE SCIENTIFIC INC.JRC2025-07-07
00840095689137Globe Scientific GLOBE SCIENTIFIC INC.JRC2025-07-07