Instant Technologies, Inc.

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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, Amphetamine (DKZ) (4) Enzyme Immunoassay, Cocaine And Cocaine Metabolites (DIO) (4) Enzyme Immunoassay, Opiates (DJG) (4) Enzyme Immunoassay, Phencyclidine (LCM) (4) Thin Layer Chromatography, Methamphetamine (DJC) (4) Enzyme Immunoassay, Barbiturate (DIS) (3) Enzyme Immunoassay, Benzodiazepine (JXM) (3) Enzyme Immunoassay, Cannabinoids (LDJ) (3) Enzyme Immunoassay, Methadone (DJR) (2) Enzyme Immunoassay, Propoxyphene (JXN) (2) Gas Chromatography, Methamphetamine (LAF) (2) U.V. Spectrometry, Tricyclic Antidepressant Drugs (LFH) (2)

Premarket Exempt

No Yes

Clear

Alere Oratect - 00817405020003 Catalog Number : AOT-06

Device Description : Drug screen test for detection of Methamphetamine, Marijuana, Cocaine, Amphetami Drug screen test for detection of Methamphetamine, Marijuana, Cocaine, Amphetamine, Opiate and Phencyclidine in human oral fluid.

Device Class : 2

Duns Number: 019410187

Premarket Exempt : No

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

Prescription Use : Yes

Device Count : 1

Alere iCup Dx 14 - 00817405020010 Catalog Number : I-DX-1147-022

Device Description : Urine Drug Screen Cup for detection of 14 drugs, Amphetamine, Barbiturate, Benzo Urine Drug Screen Cup for detection of 14 drugs, Amphetamine, Barbiturate, Benzodiazepine, Buprenorphine, Cocaine, Ecstasy, Marijuana, Methamphetamine, Methadone, Morphine, Oxycodone, Phencyclidine, Propoxyphene and Tricyclic Antidepressants, CLIA Waived

Device Class : 2

Duns Number: 019410187

Premarket Exempt : No

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

Prescription Use : Yes

Device Count : 1

Alere iCup Dx 14 - 00817405020027 Catalog Number : I-DXA-2147-011

Device Description : Urine Drug Screen Cup for detection of 14 drugs, Amphetamine, Barbiturate, Benzo Urine Drug Screen Cup for detection of 14 drugs, Amphetamine, Barbiturate, Benzodiazepine, Buprenorphine, Cocaine, Ecstasy, Marijuana, Methadone, Methamphetamine, Morphine, Oxycodone, Phencyclidine, Propoxyphene and Tricyclic Antidepressants with adulteration tests, Bleach, Creatinine, Nitrite, pH and Specific Gravity, CLIA Waived

Device Class : 2

Duns Number: 019410187

Premarket Exempt : No

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

Prescription Use : Yes

Device Count : 1

Alere iScreen Dx - 00817405020034 Catalog Number : IS1 PCP-DX

Device Description : Urine Drug Screen Card for detection of Phencyclidine (PCP) single drug, CLIA Waived

Device Class : U

Duns Number: 019410187

Premarket Exempt : No

Product Code : LCM

Prescription Use : Yes

Device Count : 1

Alere iScreen Dx - 00817405020041 Catalog Number : IS1 AMP-DX

Device Description : Urine Drug Screen Card for detection of Amphetamine (AMP) single drug, CLIA Waived

Device Class : 2

Duns Number: 019410187

Premarket Exempt : No

Product Code : DKZ

Prescription Use : Yes

Device Count : 1

Alere iScreen Dx - 00817405020058 Catalog Number : IS1 BAR-DX

Device Description : Urine Drug Screen Card for detection of Barbiturate (BAR) single drug, CLIA Waived

Device Class : 2

Duns Number: 019410187

Premarket Exempt : No

Product Code : DIS

Prescription Use : Yes

Device Count : 1

Alere iScreen Dx - 00817405020065 Catalog Number : IS1 BZO-DX

Device Description : Urine Drug Screen Card for detection of Benzodiazepine (BZO) single drug, CLIA Waived

Device Class : 2

Duns Number: 019410187

Premarket Exempt : No

Product Code : JXM

Prescription Use : Yes

Device Count : 1

Alere iScreen Dx - 00817405020072 Catalog Number : IS1 COC-DX

Device Description : Urine Drug Screen Card for detection of Cocaine (COC) single drug, CLIA Waived

Device Class : 2

Duns Number: 019410187

Premarket Exempt : No

Product Code : DIO

Prescription Use : Yes

Device Count : 1

Alere iScreen Dx - 00817405020089 Catalog Number : IS1 MOP-DX

Device Description : Urine Drug Screen Card for detection of Morphine (MOP) single drug, CLIA Waived

Device Class : 2

Duns Number: 019410187

Premarket Exempt : No

Product Code : DJG

Prescription Use : Yes

Device Count : 1

Alere iScreen Dx - 00817405020096 Catalog Number : IS1 MDM-DX

Device Description : Urine Drug Screen Card for detection of Ecstasy (MDMA) single drug, CLIA Waived

Device Class : 2

Duns Number: 019410187

Premarket Exempt : No

Product Code : DJC

Prescription Use : Yes

Device Count : 1

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