MEDTOX DIAGNOSTICS, INC.

MEDTOX DIAGNOSTICS, INC.

Address:1238 Anthony Rd,BURLINGTON,NC,27215,US

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Device Class

Class-1 (A medical device with low to moderate risk that requires general controls) Class-2 (A medical device with a moderate to high risk that requires special controls) Class-3 (A medical device with high risk that requires premarket approval) Class-U (Unclassified)

Product Code

Enzyme Immunoassay, Opiates (DJG) (5) Enzyme Immunoassay, Amphetamine (DKZ) (5) Enzyme Immunoassay, Barbiturate (DIS) (5) Enzyme Immunoassay, Benzodiazepine (JXM) (5) Enzyme Immunoassay, Cannabinoids (LDJ) (5) Enzyme Immunoassay, Cocaine And Cocaine Metabolites (DIO) (5) Enzyme Immunoassay, Phencyclidine (LCM) (5) Enzyme Immunoassay, Methadone (DJR) (4) Thin Layer Chromatography, Methamphetamine (DJC) (3) High Pressure Liquid Chromatography, Tricyclic Antidepressant Drugs (LFI) (3) Multi-Analyte Controls Unassayed (OHQ) (2) Enzyme Immunoassay, Propoxyphene (JXN) (2) Colorimeter, Photometer, Spectrophotometer For Clinical Use (JJQ) (1) Micro Pipette (JRC) (1) Reagents, Test, Tetrahydrocannabinol (DKE) (1)

Premarket Exempt

No Yes

Clear

PROFILE®-V MEDTOXScan® - 00690286000018 Catalog Number :

Device Description : A qualitative one-step immunochromatographic test panel for the detection of THC A qualitative one-step immunochromatographic test panel for the detection of THC (Cannabinoids), Phencyclidine, Cocaine, Methamphetamine (MAMP), Opiates, Amphetamine, Benzodiazepines, Tricyclic Antidepressants, Methadone, Barbiturates, Oxycodone, and Propoxyphene drugs and/or metabolites in human urine.

Device Class :

Duns Number: 137417965

Premarket Exempt : No

Product Code : LDJ, JXN, DIS, DJR, LFI, JXM, DKZ, DJG, DJC, DIO, LCM

Prescription Use : Yes

Device Count : 1

PROFILE®-V MEDTOXScan® - 00690286000025 Catalog Number :

Device Description : A qualitative one-step immunochromatographic test panel for the detection of THC A qualitative one-step immunochromatographic test panel for the detection of THC (Cannabinoids), Phencyclidine, Cocaine, Opiates, Amphetamine, Benzodiazepines, Tricyclic Antidepressants, Methadone, and Barbiturates drugs and/or metabolites in human urine.

Device Class : 2

Duns Number: 137417965

Premarket Exempt : No

Product Code : DIS, DJR, LFI, JXM, DKZ, DJG, DIO, LCM, LDJ

Prescription Use : Yes

Device Count : 1

PROFILE®-V MEDTOXScan® - 00690286000032 Catalog Number :

Device Description : A qualitative one-step immunochromatographic test panel for the detection of THC A qualitative one-step immunochromatographic test panel for the detection of THC (Cannabinoids), Phencyclidine, Cocaine, Opiates, Amphetamine, Benzodiazepines, and Barbiturates drugs and/or metabolites in human urine.

Device Class : 2

Duns Number: 137417965

Premarket Exempt : No

Product Code : DIS, JXM, DKZ, DJG, DIO, LCM, LDJ

Prescription Use : Yes

Device Count : 1

PROFILE®-V MEDTOXScan® - 00690286000049 Catalog Number :

Device Description : A qualitative one-step immunochromatographic test panel for the detection of THC A qualitative one-step immunochromatographic test panel for the detection of THC (Cannabinoids), Phencyclidine, Cocaine, Methamphetamine (MAMP), Opiates, Amphetamine, Benzodiazepines, Tricyclic Antidepressants, Methadone, Barbiturates, Oxycodone, Propoxyphene, and Buprenorphine drugs and/or metabolites in human urine.

Device Class :

Duns Number: 137417965

Premarket Exempt : No

Product Code : DJG, JXN, DJR, LFI, DIS, JXM, DKZ, DJC, DIO, LCM, LDJ

Prescription Use : Yes

Device Count : 1

PROFILE®-V MEDTOXScan® - 00690286000056 Catalog Number :

Device Description : A qualitative one-step immunochromatographic test panel for the detection of THC A qualitative one-step immunochromatographic test panel for the detection of THC (Cannabinoids), Phencyclidine, Cocaine, Methamphetamine (MAMP), Opiates, Amphetamine, Benzodiazepines, Methadone, Barbiturates, and Oxycodone drugs and/or metabolites in human urine.

Device Class : 2

Duns Number: 137417965

Premarket Exempt : No

Product Code : DIS, DJR, JXM, DKZ, DJG, DJC, DIO, LCM, LDJ

Prescription Use : Yes

Device Count : 1

MEDTOXScan® Reader - 00690286000063 Catalog Number :

Device Description : An instrument used to interpret and report the results of the PROFILE®-V MEDTOXS 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.

Device Class : 1

Duns Number: 137417965

Premarket Exempt : No

Product Code : JJQ

Prescription Use : Yes

Device Count : 1

MEDTOXScan® QC Test Devices - 00690286000070 Catalog Number :

Device Description : QC Test Devices used to detect errors associated with the MEDTOXScan® Reader and QC Test Devices used to detect errors associated with the MEDTOXScan® Reader and a contaminated contact imaging sensor (CIS), and to verify that the CIS cleaning procedure using the MEDTOXScan® Cleaning Cassette effectively removed any contamination. QC Test Devices are intended to function as an optical performance system check for the MEDTOXScan® Reader only, and not intended to replace the need for external controls.

Device Class : 1

Duns Number: 137417965

Premarket Exempt : No

Product Code : OHQ

Prescription Use : Yes

Device Count : 1

MEDTOXScan® Cleaning Cassette - 00690286000087 Catalog Number :

Device Description : A cleaning cassette solely intended to clean the color Contact Imaging Sensor (C A cleaning cassette solely intended to clean the color Contact Imaging Sensor (CIS) in the MEDTOXScan® Reader.

Device Class : 1

Duns Number: 137417965

Premarket Exempt : No

Product Code : OHQ

Prescription Use : Yes

Device Count : 1

MEDTOXScan® - 00690286000094 Catalog Number :

Device Description : A micro pipette designed to dispense an accurate volume of sample for the PROFIL A micro pipette designed to dispense an accurate volume of sample for the PROFILE®-V MEDTOXScan® Test Devices.

Device Class : 1

Duns Number: 137417965

Premarket Exempt : No

Product Code : JRC

Prescription Use : Yes

Device Count : 1

VERDICT®-II - 00690286000100 Catalog Number :

Device Description : A qualitative one-step immunochromatographic test for the detection of Cannabino A qualitative one-step immunochromatographic test for the detection of Cannabinoids (THC) and/or metabolites in human urine.

Device Class :

Duns Number: 137417965

Premarket Exempt : No

Product Code : DKE

Prescription Use : Yes

Device Count : 1

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