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, Cannabinoids (LDJ) (6) Thin Layer Chromatography, Methamphetamine (DJC) (6) Enzyme Immunoassay, Opiates (DJG) (6) Enzyme Immunoassay, Amphetamine (DKZ) (5) Enzyme Immunoassay, Cocaine And Cocaine Metabolites (DIO) (5) Enzyme Immunoassay, Methadone (DJR) (5) Enzyme Immunoassay, Benzodiazepine (JXM) (4) Enzyme Immunoassay, Barbiturate (DIS) (4) Enzyme Immunoassay, Phencyclidine (LCM) (3) U.V. Spectrometry, Tricyclic Antidepressant Drugs (LFH) (2)

Premarket Exempt

No Yes

Clear

Alere iScreen Dx - 00817405020102 Catalog Number : IS1 MET-DX

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

Device Class : 2

Duns Number: 019410187

Premarket Exempt : No

Product Code : DJC

Prescription Use : Yes

Device Count : 1

Alere iScreen Dx - 00817405020119 Catalog Number : IS1 MTD-DX

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

Device Class : 2

Duns Number: 019410187

Premarket Exempt : No

Product Code : DJR

Prescription Use : Yes

Device Count : 1

Alere iScreen Dx - 00817405020126 Catalog Number : IS1 TCA-DX

Device Description : Urine Drug Screen Card for detection of Tricyclic Antidepressants (TCA) single d Urine Drug Screen Card for detection of Tricyclic Antidepressants (TCA) single drug, CLIA Waived

Device Class : 2

Duns Number: 019410187

Premarket Exempt : No

Product Code : LFH

Prescription Use : Yes

Device Count : 1

Alere iScreen Dx - 00817405020133 Catalog Number : IS1 THC-DX

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

Device Class : 2

Duns Number: 019410187

Premarket Exempt : No

Product Code : LDJ

Prescription Use : Yes

Device Count : 1

Alere iScreen Dx - 00817405020140 Catalog Number : IS1 BUP-DX

Device Description : Urine Drug Screen Card for detection of Buprenorphine (BUP) 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 - 00817405020157 Catalog Number : IS10-22015-DX

Device Description : Urine Drug Screen Card for detection of 10 drugs, Amphetamine, Barbiturate, Benz Urine Drug Screen Card for detection of 10 drugs, Amphetamine, Barbiturate, Benzodiazepine, Cocaine, Ecstasy, Marijuana, Methadone, Methamphetamine, Morphine and Phencyclidine, CLIA Waived

Device Class : 2

Duns Number: 019410187

Premarket Exempt : No

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

Prescription Use : Yes

Device Count : 1

Alere iScreen Dx - 00817405020164 Catalog Number : IS10-DX

Device Description : Urine Drug Screen Card for detection of 10 drugs, Amphetamine, Barbiturate, Benz Urine Drug Screen Card for detection of 10 drugs, Amphetamine, Barbiturate, Benzodiazepine, Cocaine, Marijuana, Methadone, Methamphetamine, Morphine, Oxycodone and Phencyclidine, CLIA Waived

Device Class : 2

Duns Number: 019410187

Premarket Exempt : No

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

Prescription Use : Yes

Device Count : 1

Alere iScreen Dx - 00817405020171 Catalog Number : IS12-DX

Device Description : Urine Drug Screen Card for detection of 12 drugs, Amphetamine, Barbiturate, Benz Urine Drug Screen Card for detection of 12 drugs, Amphetamine, Barbiturate, Benzodiazepine, Cocaine, Ecstasy, Marijuana, Methadone, Methamphetamine, Morphine, Oxycodone, Phencyclidine and Tricyclic Antidepressants, CLIA Waived

Device Class : 2

Duns Number: 019410187

Premarket Exempt : No

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

Prescription Use : Yes

Device Count : 1

Alere iScreen Dx - 00817405020188 Catalog Number : IS5 M-DX

Device Description : Urine Drug Screen Card for detection of 5 drugs, Amphetamine, Cocaine, Marijuana Urine Drug Screen Card for detection of 5 drugs, Amphetamine, Cocaine, Marijuana, Methamphetamine and Morphine, CLIA Waived

Device Class : 2

Duns Number: 019410187

Premarket Exempt : No

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

Prescription Use : Yes

Device Count : 1

Alere iScreen Dx - 00817405020195 Catalog Number : IS10 BUP-DX

Device Description : Urine Drug Screen Card for detection of 10 drugs, Amphetamine, Barbiturate, Benz Urine Drug Screen Card for detection of 10 drugs, Amphetamine, Barbiturate, Benzodiazepine, Buprenorphjne, Cocaine, Marijuana, Methadone, Methamphetamine, Morphine and Oxycodone, CLIA Waived

Device Class : 2

Duns Number: 019410187

Premarket Exempt : No

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

Prescription Use : Yes

Device Count : 1

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