FDA.reportPublic FDA data

PROFILE®-V MEDTOXScan®

Primary DI
10690286000756
Brand
PROFILE®-V MEDTOXScan®
Company
MEDTOX DIAGNOSTICS, INC.
Model
604031
Device description
A qualitative one-step immunochromatographic test panel for the detection of THC (Cannabinoids), Phencyclidine, Cocaine, Methamphetamine (MAMP), Opiates, Amphetamine, Benzodiazepines, Tricyclic Antidepressants, Methadone, Barbiturates, and Oxycodone drugs and/or metabolites in human urine.
Published
2023-08-01
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
LFIHigh Pressure Liquid Chromatography, Tricyclic Antidepressant Drugs

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LFIHigh Pressure Liquid Chromatography, Tricyclic Antidepressant DrugsClinical Toxicology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K080635000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K080635000MEDTOXSCANMedtox Diagnostics, Inc.2009-02-13DKZ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10690286000756PackageGS125In Commercial Distribution
00690286000759PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1069028600075610690286000756
00690286000759006902860007596902860007590690286000759

GMDN Terms#

Term, Definition table
TermDefinition
Multiplex analyser IVD, laboratoryAn electrically-powered automated or semi-automated 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.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature2 Degrees Celsius25 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

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

Regulatory Flags#

DUNS number
137417965
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
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
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
00860001286526TrakTRK-0-1 Rev 32021-06-23

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10694644300793RDSAMERICAN BIO MEDICA CORPORATIONLFI2021-07-22
10694644400745INCUPAMERICAN BIO MEDICA CORPORATIONLFI2021-06-24
10694644300786RDSAMERICAN BIO MEDICA CORPORATIONLFI2021-06-10
10694644300779RDSAMERICAN BIO MEDICA CORPORATIONLFI2021-05-28
10694644200505RTCII 1st gen.AMERICAN BIO MEDICA CORPORATIONLFI2019-10-03
10694644200499RTCII 1st gen.AMERICAN BIO MEDICA CORPORATIONLFI2019-09-28
10694644400714INCUPAMERICAN BIO MEDICA CORPORATIONLFI2019-03-11
10694644300762RDSAMERICAN BIO MEDICA CORPORATIONLFI2019-02-13
10694644400707INCUPAMERICAN BIO MEDICA CORPORATIONLFI2018-10-29
10694644300755RDSAMERICAN BIO MEDICA CORPORATIONLFI2018-09-14
10694644300748RDSAMERICAN BIO MEDICA CORPORATIONLFI2018-07-05
10694644200482RTCII 1st gen.AMERICAN BIO MEDICA CORPORATIONLFI2018-05-23
10694644300731RDSAMERICAN BIO MEDICA CORPORATIONLFI2018-05-23
10694644400691INCUPAMERICAN BIO MEDICA CORPORATIONLFI2018-04-20
10694644200475RTCII 1st gen.AMERICAN BIO MEDICA CORPORATIONLFI2018-04-19
10694644300724RDSAMERICAN BIO MEDICA CORPORATIONLFI2018-04-19
10694644300694RDSAMERICAN BIO MEDICA CORPORATIONLFI2018-03-23
10694644300700RDSAMERICAN BIO MEDICA CORPORATIONLFI2018-03-23
10694644300717RDSAMERICAN BIO MEDICA CORPORATIONLFI2018-03-23
10694644400684INCUPAMERICAN BIO MEDICA CORPORATIONLFI2018-02-16
10694644300687RDSAMERICAN BIO MEDICA CORPORATIONLFI2018-02-13
10694644200468RTCII 1st gen.AMERICAN BIO MEDICA CORPORATIONLFI2017-10-18
10694644200451RTCII 1st gen.AMERICAN BIO MEDICA CORPORATIONLFI2017-10-12
10694644400677INCUPAMERICAN BIO MEDICA CORPORATIONLFI2017-10-10
10694644200444RTCII 1st gen.AMERICAN BIO MEDICA CORPORATIONLFI2017-06-29
10694644300663RDSAMERICAN BIO MEDICA CORPORATIONLFI2017-06-08
10694644300670RDSAMERICAN BIO MEDICA CORPORATIONLFI2017-06-08
10694644400660INCUPAMERICAN BIO MEDICA CORPORATIONLFI2017-05-05
10694644300649RDSAMERICAN BIO MEDICA CORPORATIONLFI2017-04-06
10694644300656RDSAMERICAN BIO MEDICA CORPORATIONLFI2017-04-06