AMEDITECH INC.

Address:9940 Mesa Rim Rd,SAN DIEGO,CA,92121,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, Cocaine And Cocaine Metabolites (DIO) (4) Enzyme Immunoassay, Amphetamine (DKZ) (4) Enzyme Immunoassay, Cannabinoids (LDJ) (4) Enzyme Immunoassay, Opiates (DJG) (3) Thin Layer Chromatography, Methamphetamine (DJC) (3) Enzyme Immunoassay, Barbiturate (DIS) (3) Enzyme Immunoassay, Benzodiazepine (JXM) (3) Enzyme Immunoassay, Phencyclidine (LCM) (2) Radioimmunoassay, Tricyclic Antidepressant Drugs (LFG) (2) Enzyme Immunoassay, Methadone (DJR) (2) Gas Chromatography, Methamphetamine (LAF) (1)

Premarket Exempt

No Yes

Clear

ToxCup Drug Screen Cup - 00816555020390 Catalog Number : HT23

Device Description : ToxCup® Drug Screen Cup (AMP300/COC300/MET500/OPI300/THC50/MDMA500/MTD300)

Device Class : 2

Duns Number: 010551716

Premarket Exempt : No

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

Prescription Use : Yes

Device Count : 1

ImmuTest Drugs of Abuse Screen Card - 00816565020007 Catalog Number : IMD-AMP

Device Description : Amphetamine single drug dipcard

Device Class : 2

Duns Number: 010551716

Premarket Exempt : No

Product Code : DKZ

Prescription Use : Yes

Device Count : 1

ImmuTest Drugs of Abuse Screen Card - 00816565020014 Catalog Number : IMD-BAR

Device Description : Barbiturate single drug dipcard

Device Class : 2

Duns Number: 010551716

Premarket Exempt : No

Product Code : DIS

Prescription Use : Yes

Device Count : 1

ImmuTest Drugs of Abuse Screen Card - 00816565020021 Catalog Number : IMD-BZO

Device Description : Benzodiazepine single drug dipcard

Device Class : 2

Duns Number: 010551716

Premarket Exempt : No

Product Code : JXM

Prescription Use : Yes

Device Count : 1

ImmuTest Drugs of Abuse Screen Card - 00816565020038 Catalog Number : IMD-COC

Device Description : Cocaine single drug dipcard

Device Class : 2

Duns Number: 010551716

Premarket Exempt : No

Product Code : DIO

Prescription Use : Yes

Device Count : 1

ImmuTest Drugs of Abuse Screen Card - 00816565020045 Catalog Number : IMD-MET

Device Description : Methamphetamine single drug dipcard

Device Class : 2

Duns Number: 010551716

Premarket Exempt : No

Product Code : DJC

Prescription Use : Yes

Device Count : 1

ImmuTest Drugs of Abuse Screen Card - 00816565020052 Catalog Number : IMD-OPI300

Device Description : Opiate 300 single drug dipcard

Device Class : 2

Duns Number: 010551716

Premarket Exempt : No

Product Code : DJG

Prescription Use : Yes

Device Count : 1

ImmuTest Drugs of Abuse Screen Card - 00816565020069 Catalog Number : IMD-THC

Device Description : THC single drug dipcard

Device Class : 2

Duns Number: 010551716

Premarket Exempt : No

Product Code : LDJ

Prescription Use : Yes

Device Count : 1

ImmuTest Drugs of Abuse Screen Card - 00816565020076 Catalog Number : IMD-12MO3

Device Description : (BZO/BAR)+(COC/THC)+(MTD/TCA)+(OXY/MDMA)+(PCP/AMP)+ MET1000 + OPI300 multiple dr (BZO/BAR)+(COC/THC)+(MTD/TCA)+(OXY/MDMA)+(PCP/AMP)+ MET1000 + OPI300 multiple drugs dipcard

Device Class : 2

Duns Number: 010551716

Premarket Exempt : No

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

Prescription Use : Yes

Device Count : 1

ImmuTest Drugs of Abuse Screen Card - 00816565020083 Catalog Number : IMD-8MT

Device Description : (BZO/BAR)+(COC/THC)+(PCP/AMP)+MET1000+TCA multiple drugs dipcard

Device Class : 2

Duns Number: 010551716

Premarket Exempt : No

Product Code : LFG, DJC, DKZ, LCM, LDJ, DIO, DIS, JXM

Prescription Use : Yes

Device Count : 1

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