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) (10) Enzyme Immunoassay, Amphetamine (DKZ) (9) Enzyme Immunoassay, Cocaine And Cocaine Metabolites (DIO) (9) Enzyme Immunoassay, Benzodiazepine (JXM) (7) Enzyme Immunoassay, Phencyclidine (LCM) (7) Enzyme Immunoassay, Cannabinoids (LDJ) (6) Thin Layer Chromatography, Methamphetamine (DJC) (5) Enzyme Immunoassay, Barbiturate (DIS) (5) Enzyme Immunoassay, Propoxyphene (JXN) (3) Reagents, Test, Tetrahydrocannabinol (DKE) (3) Enzyme Immunoassay, Methadone (DJR) (2) Radioimmunoassay, Tricyclic Antidepressant Drugs (LFG) (1)

Premarket Exempt

No Yes

Clear

PROFILE-II ER® - 00690286000315 Catalog Number :

Device Description : A qualitative one-step immunochromatographic test panel for the detection of Can A qualitative one-step immunochromatographic test panel for the detection of Cannabinoids (THC), Opiates, Amphetamines, Cocaine, Phencyclidine, Tricyclic Antidepressants, Barbiturates, Methadone, Benzodiazepines, Propoxyphene (PPX), Methamphetamine (MAMP), 3,4-Methylenedioxymethamphetamine (MDMA) and Oxycodone drugs and/or metabolites in human urine.

Device Class :

Duns Number: 137417965

Premarket Exempt : No

Product Code : JXN, DIS, DJR, LFG, JXM, DKZ, DJG, DJC, DIO, LCM, DKE

Prescription Use : Yes

Device Count : 1

MEDTOX® OXYCODONE - 00690286000322 Catalog Number :

Device Description : A qualitative one-step immunochromatographic test for the detection of Oxycodone A qualitative one-step immunochromatographic test for the detection of Oxycodone and/or metabolites in human urine.

Device Class : 2

Duns Number: 137417965

Premarket Exempt : No

Product Code : DJG

Prescription Use : Yes

Device Count : 1

PROFILE®-II - 00690286000339 Catalog Number :

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

Device Class :

Duns Number: 137417965

Premarket Exempt : No

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

Prescription Use : Yes

Device Count : 1

PROFILE®-IIA - 00690286000346 Catalog Number :

Device Class :

Duns Number: 137417965

Premarket Exempt : No

Product Code : DKZ, DJG, DIO, LCM, DKE

Prescription Use : Yes

Device Count : 1

PROFILE®-IIA - 00690286000353 Catalog Number :

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

Device Class :

Duns Number: 137417965

Premarket Exempt : No

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

Prescription Use : Yes

Device Count : 1

PROFILE®-IIA - 00690286000360 Catalog Number :

Device Description : A qualitative one-step immunochromatographic test panel for the detection of Can A qualitative one-step immunochromatographic test panel for the detection of Cannabinoids (THC), Opiates, Amphetamine, Cocaine, Phencyclidine, Barbiturates, Benzodiazepines, Oxycodone, Methamphetamine (MAMP), 3,4-Methylenedioxymethamphetamine (MDMA), and Propoxyphene drugs and/or their metabolites in human urine.

Device Class :

Duns Number: 137417965

Premarket Exempt : No

Product Code : JXN, DIS, JXM, DKZ, DJG, DJC, DIO, LCM, DKE

Prescription Use : Yes

Device Count : 1

SURE-SCREEN® - 00690286000377 Catalog Number :

Device Description : A rapid screening test system for the detection of Amphetamine, Benzodiazepines, A rapid screening test system for the detection of Amphetamine, Benzodiazepines, Cocaine, Opiates, and THC (Cannabinoids) drugs and/or their metabolites in human urine.

Device Class :

Duns Number: 137417965

Premarket Exempt : No

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

Prescription Use : Yes

Device Count : 1

SURE-SCREEN® - 00690286000384 Catalog Number :

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

Device Class : 2

Duns Number: 137417965

Premarket Exempt : No

Product Code : JXM, DKZ, DJG, DJC, DIO, LDJ

Prescription Use : Yes

Device Count : 1

SURE-SCREEN® - 00690286000391 Catalog Number :

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

Device Class :

Duns Number: 137417965

Premarket Exempt : No

Product Code : DKZ, DJG, DJC, DIO, LDJ, LCM

Prescription Use : Yes

Device Count : 1

SURE-SCREEN® - 00690286000407 Catalog Number :

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

Device Class : 2

Duns Number: 137417965

Premarket Exempt : No

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

Prescription Use : Yes

Device Count : 1

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