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, Barbiturate (DIS) (8) Enzyme Immunoassay, Methadone (DJR) (8) Enzyme Immunoassay, Opiates (DJG) (7) Enzyme Immunoassay, Benzodiazepine (JXM) (7) Enzyme Immunoassay, Amphetamine (DKZ) (7) Enzyme Immunoassay, Cocaine And Cocaine Metabolites (DIO) (7) Enzyme Immunoassay, Cannabinoids (LDJ) (6) Thin Layer Chromatography, Methamphetamine (DJC) (5) Radioimmunoassay, Tricyclic Antidepressant Drugs (LFG) (5) Enzyme Immunoassay, Phencyclidine (LCM) (4) Test, Amphetamine, Over The Counter (NFT) (2) Test, Cannabinoid, Over The Counter (NFW) (2) Test, Cocaine And Cocaine Metabolites, Over The Counter (NFY) (2) Test, Benzodiazepine, Over The Counter (NFV) (2) Test, Opiates, Over The Counter (NGL) (2) Test, Methamphetamine, Over The Counter (NGG) (2) Test, Methamphetamine, Employment And Insurance Testing, Exempt (PVD) (1) Test, Opiates, Employment And Insurance Testing, Exempt (PVH) (1) Gas Chromatography, Methamphetamine (LAF) (1) Test, Amphetamine, Employment And Insurance Testing, Exempt (PUX) (1) Test, Barbiturate, Employment And Insurance Testing, Exempt (PUY) (1) Test, Benzodiazepine, Employment And Insurance Testing, Exempt (PUZ) (1) Test, Cannabinoid, Employment And Insurance Testing, Exempt (PVJ) (1) Test, Cocaine And Cocaine Metabolite, Employment And Insurance Testing, Exempt (PVA) (1) Test, Methadone, Employment And Insurance Testing, Exempt (PVE) (1)

Premarket Exempt

No Yes

Clear

Alere iCup Dx Pro - 00817405020300 Catalog Number : I-DXP-1117-01

Device Description : Urine Drug Screening Device for detection of Amphetamine, Barbiturate, Benzodiaz Urine Drug Screening Device for detection of Amphetamine, Barbiturate, Benzodiazepine, Cocaine, Ecstasy, Marijuana, Methamphetamine, Methadone, Opiate (300), Oxycodone and Tricyclic Antidepressants with adulteration tests for Oxidant, pH and Specific Gravity. CLIA Waived Test Cup

Device Class : 2

Duns Number: 019410187

Premarket Exempt : No

Product Code : NFW, NGL, NGG, NFY, NFV, NFT, DIS, DJR, LFG

Prescription Use : Yes

Device Count : 1

Alere iCup Dx Pro - 00817405020317 Catalog Number : I-DXP-1127-02

Device Description : Urine Drug Screening Device for detection of Amphetamine, Barbiturate, Benzodiaz Urine Drug Screening Device for detection of Amphetamine, Barbiturate, Benzodiazepine, Cocaine, Ecstasy, Marijuana, Methamphetamine, Methadone, Opiate (300), Oxycodone, Phencyclidine and Tricyclic Antidepressants. CLIA Waived Test Cup

Device Class : 2

Duns Number: 019410187

Premarket Exempt : No

Product Code : LCM, LFG, DJR, DIS, NFT, NFV, NFY, NGG, NGL, NFW

Prescription Use : Yes

Device Count : 1

Alere iCup Dx - 00817405020324 Catalog Number : I-DXA-1127-023-N

Device Description : Drugs of Abuse Test Cup for detection of BZO+BAR+(COC/THC)+(MET1000/OPI2000)+(MT Drugs of Abuse Test Cup for detection of BZO+BAR+(COC/THC)+(MET1000/OPI2000)+(MTD/TCA)+(OXY/MDMA)+(PCP/AMP) with adulteration tests Cr, Ni, pH, Bl, S.G., CLIA Waived

Device Class : 2

Duns Number: 019410187

Premarket Exempt : No

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

Prescription Use : Yes

Device Count : 1

Alere iCup Dx - 00817405020331 Catalog Number : I-DXA-1107-142-N

Device Description : Drugs of Abuse Test Cup for detection of BZO+BAR+(MET1000/OPI2000)+(OXY/MDMA)+AM Drugs of Abuse Test Cup for detection of BZO+BAR+(MET1000/OPI2000)+(OXY/MDMA)+AMP+COC+MTD+THC with adulteration tests Cr, Ni,pH, Bl, S.G., CLIA Waived

Device Class : 2

Duns Number: 019410187

Premarket Exempt : No

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

Prescription Use : Yes

Device Count : 1

Alere iCup Dx - 00817405020348 Catalog Number : I-DXA-1117-131-N

Device Description : Drugs of Abuse Test Cup for detection of BZO+BAR+(MET/OPI)+(MTD/TCA)+(OXY/MDMA)+ Drugs of Abuse Test Cup for detection of BZO+BAR+(MET/OPI)+(MTD/TCA)+(OXY/MDMA)+(PCP/AMP)+COC with adulteration tests Cr, Ni, pH, Bl, S.G., CLIA Waived

Device Class : 2

Duns Number: 019410187

Premarket Exempt : No

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

Prescription Use : Yes

Device Count : 1

Alere iCup Dx Pro 2 - 00817405020355 Catalog Number : I-DXP-2107-01

Device Description : iCup Dx Pro 2 Integrated CLIA Waived Cup with Adulterants (CR,SG,OX) 10 Panel Dr iCup Dx Pro 2 Integrated CLIA Waived Cup with Adulterants (CR,SG,OX) 10 Panel Drug Screen for (AMP/BAR/BUP/BZO/COC/MET/OPI300/OXY/MTD/THC)

Device Class : 2

Duns Number: 019410187

Premarket Exempt : No

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

Prescription Use : Yes

Device Count : 1

Alere iCup Dx Pro 2 - 00817405020362 Catalog Number : I-DXP-167-02

Device Description : iCup Dx Pro 2 Integrated CLIA Waived Cup with Adulterants (CR,SG,OX) 6 Panel Dru iCup Dx Pro 2 Integrated CLIA Waived Cup with Adulterants (CR,SG,OX) 6 Panel Drug Screen for (COC/OPI300/AMP/OXY/BZO/THC)

Device Class : 2

Duns Number: 019410187

Premarket Exempt : No

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

Prescription Use : Yes

Device Count : 1

Alere iCUP DX - 00817405020379 Catalog Number : I-DXA-13B

Device Description : Alere iCUP DX (THC50/COC150)+(MOP300/MET500)+(AMP500/BZO300)+(BAR300/MTD300)+(MD Alere iCUP DX (THC50/COC150)+(MOP300/MET500)+(AMP500/BZO300)+(BAR300/MTD300)+(MDMA500/OXY100) +(BUPG10/TCA1000)+PCP25 With Cr, Ni, pH, Bl, S.G.

Device Class : 2

Duns Number: 019410187

Premarket Exempt : No

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

Prescription Use : Yes

Device Count : 1

Alere iCUP DX - 00817405020386 Catalog Number : I-DXA-10

Device Class : 2

Duns Number: 019410187

Premarket Exempt : No

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

Prescription Use : Yes

Device Count : 1

T-Cube® - 00817405020393 Catalog Number : Tcube-10PCP

Device Description : T-Cube ® One Step Multi-Drug Oral Fluid Test Cube offers qualitative detection o 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, BZO, COC, MET, MTD, OPI, OXY, PCP, THC.

Device Class : 2

Duns Number: 019410187

Premarket Exempt : Yes

Product Code : PVD, PUZ, PVA, PUY, PVE, PUX, PVH, PVJ

Prescription Use : No

Device Count : 1

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