FDA.reportPublic FDA data

VERDICT®-II

Primary DI
00690286000254
Brand
VERDICT®-II
Company
MEDTOX DIAGNOSTICS, INC.
Model
601645
Device description
A qualitative one-step immunochromatographic test panel for the detection of Cannabinoids (THC), Opiates, Cocaine, Methamphetamine (MAMP), 3,4-Methylenedioxymethamphetamine (MDMA) drugs and/or their metabolites in human urine.
Published
2016-09-16
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
DIOEnzyme Immunoassay, Cocaine And Cocaine Metabolites
DJCThin Layer Chromatography, Methamphetamine
DJGEnzyme Immunoassay, Opiates
LDJEnzyme Immunoassay, Cannabinoids

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DIOEnzyme Immunoassay, Cocaine And Cocaine MetabolitesClinical Toxicology2
DJCThin Layer Chromatography, MethamphetamineClinical Toxicology2
DJGEnzyme Immunoassay, OpiatesClinical Toxicology2
LDJEnzyme Immunoassay, CannabinoidsClinical Toxicology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K010226000
K031032000
K982211000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K010226000VERDICT -II METHAMPHETAMINEMedtox Diagnostics, Inc.2001-06-01DJC
K031032000VERDICT II, PROFILE IIMedtox Diagnostics, Inc.2003-07-14DJG
K982211000PROFILE-II MODEL 600582Medtox Diagnostics, Inc.1998-07-29DKE

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10690286000251PackageGS125Not in Commercial Distribution
00690286000254PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1069028600025110690286000251
00690286000254006902860002546902860002540690286000254

GMDN Terms#

Term, Definition table
TermDefinition
Multiple drugs of abuse IVD, kit, rapid ICT, clinicalA collection of reagents and other associated materials intended to be used for the qualitative and/or (semi-)quantitative detection of multiple drugs of abuse in a clinical specimen within a short period, relative to standard laboratory testing procedures, using an immunochromatographic test (ICT) method [lateral flow test]. This is a rapid test used in the laboratory or in point-of-care analyses. It is not intended to be used for self-testing.

Storage And Handling#

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

Contacts#

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

Regulatory Flags#

DUNS number
137417965
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
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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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