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, Cocaine And Cocaine Metabolites (DIO) (9) Enzyme Immunoassay, Amphetamine (DKZ) (9) Enzyme Immunoassay, Opiates (DJG) (9) Enzyme Immunoassay, Cannabinoids (LDJ) (9) Thin Layer Chromatography, Methamphetamine (DJC) (7) Enzyme Immunoassay, Phencyclidine (LCM) (5) Enzyme Immunoassay, Benzodiazepine (JXM) (4) Enzyme Immunoassay, Barbiturate (DIS) (3) Gas Chromatography, Methamphetamine (LAF) (3) Enzyme Immunoassay, Methadone (DJR) (2) Test, Barbiturate, Employment And Insurance Testing, Exempt (PUY) (1) Test, Cannabinoid, Employment And Insurance Testing, Exempt (PVJ) (1) Test, Cocaine And Cocaine Metabolite, Employment And Insurance Testing, Exempt (PVA) (1) Test, Opiates, Employment And Insurance Testing, Exempt (PVH) (1) Test, Amphetamine, Employment And Insurance Testing, Exempt (PUX) (1)

Premarket Exempt

No Yes

Clear

T-Cup® Compact - 00817405020560 Catalog Number : ACDOA-6125

Device Description : T-Cup® Compact Multi-Drug Urine Test Cup <AMP1000, BAR300, BUP10, BZO300, COC300 T-Cup® Compact Multi-Drug Urine Test Cup <AMP1000, BAR300, BUP10, BZO300, COC300, mAMP1000, MDMA500, MOP300, MTD300, OXY100, PCP25, THC50>

Device Class : 2

Duns Number: 019410187

Premarket Exempt : No

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

Prescription Use : No

Device Count : 1

T-Cube® - 00817405020577 Catalog Number : TCUBE-6BP

Device Description : T-Cube® One Step Multi-Drug Oral Fluid Test Cube offers qualitative detection of T-Cube® One Step Multi-Drug Oral Fluid Test Cube offers qualitative detection of the following drugs of abuse and their principal metabolites in human oral fluid at specified cut-off levels for use in employment and insurance testing: AMP, BAR, COC, OPI, PCP, and THC.

Device Class : 2

Duns Number: 019410187

Premarket Exempt : Yes

Product Code : PUX, PVH, PVJ, PVA, PUY

Prescription Use : No

Device Count : 1

ProScreen - 00817405020584 Catalog Number :

Device Description : Drugs of Abuse Cup, CLIA-Waived, AMP/COC/MET1000/OPI2000/THC

Device Class : 2

Duns Number: 019410187

Premarket Exempt : No

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

Prescription Use : Yes

Device Count : 1

ProScreen - 00817405020591 Catalog Number :

Device Description : Drugs of Abuse Cup, CLIA Waived, AMP/COC/MET1000/OPI2000/THC with Cr, Ni, pH, Bl, S.G.

Device Class : 2

Duns Number: 019410187

Premarket Exempt : No

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

Prescription Use : Yes

Device Count : 1

ProScreen - 00817405020614 Catalog Number :

Device Description : Drugs of Abuse Cup, CLIA Waived, AMP/BZO/COC/MET1000/OPI2000/THC with Cr, Ni, pH, Bl, S.G.

Device Class : 2

Duns Number: 019410187

Premarket Exempt : No

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

Prescription Use : Yes

Device Count : 1

ProScreen - 00817405020621 Catalog Number :

Device Description : Drugs of Abuse Cup, CLIA Waived, AMP/COC/MET1000/OPI2000/PCP/THC with Cr, Ni, pH, Bl, S.G.

Device Class : 2

Duns Number: 019410187

Premarket Exempt : No

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

Prescription Use : Yes

Device Count : 1

ProScreen - 00817405020652 Catalog Number :

Device Description : Drugs of Abuse Cup, (COC/THC)+(MET1000/OPI2000)+(PCP/AMP)+BAR+BZO+MDMA+MTD

Device Class : 2

Duns Number: 019410187

Premarket Exempt : No

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

Prescription Use : Yes

Device Count : 1

ProScreen - 00817405020676 Catalog Number : PSCupA-10OM

Device Description : Drugs of Abuse Cup, (COC/THC)+(MET1000/OPI2000)+(OXY/MDMA)+(PCP/AMP)+BAR+BZO wit Drugs of Abuse Cup, (COC/THC)+(MET1000/OPI2000)+(OXY/MDMA)+(PCP/AMP)+BAR+BZO with Cr, Ni, pH, Bl, S.G.

Device Class : 2

Duns Number: 019410187

Premarket Exempt : No

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

Prescription Use : Yes

Device Count : 1

ProScreen - 00817405020690 Catalog Number :

Device Description : Drugs of Abuse Test Card, AMP/COC/MET1000/OPI2000/THC

Device Class : 2

Duns Number: 019410187

Premarket Exempt : No

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

Prescription Use : Yes

Device Count : 1

ProScreen - 00817405020706 Catalog Number :

Device Description : Drugs of Abuse Test Card, AMP/COC/OPI2000/PCP/THC

Device Class : 2

Duns Number: 019410187

Premarket Exempt : No

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

Prescription Use : Yes

Device Count : 1

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