NOBLE MEDICAL 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) (10) Enzyme Immunoassay, Cannabinoids (LDJ) (10) Enzyme Immunoassay, Cocaine And Cocaine Metabolites (DIO) (10) Enzyme Immunoassay, Opiates (DJG) (10) Enzyme Immunoassay, Phencyclidine (LCM) (9) Enzyme Immunoassay, Benzodiazepine (JXM) (9) Enzyme Immunoassay, Barbiturate (DIS) (8) Enzyme Immunoassay, Methadone (DJR) (8) Thin Layer Chromatography, Methamphetamine (DJC) (8) Radioimmunoassay, Tricyclic Antidepressant Drugs (LFG) (7) Enzyme Immunoassay, Propoxyphene (JXN) (3) Gas Chromatography, Methamphetamine (LAF) (1) Test, Methamphetamine, Over The Counter (NGG) (1)

Premarket Exempt

Clear

Noble 1 Step Cup - 00858886006186 Catalog Number : NBCA-12P-W

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

Device Class : 2

Duns Number: 035967806

Premarket Exempt : No

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

Prescription Use : Yes

Device Count : 1

Noble 1 Step + Cup - 00858886006285 Catalog Number : NBCA-13A-B

Device Description : Drugs of Abuse Test Cup for THC50/COC150; OPI300/MET500; AMP500/BZ0300; BZO300/M Drugs of Abuse Test Cup for THC50/COC150; OPI300/MET500; AMP500/BZ0300; BZO300/MT300; MDMA500/OXY100; BUPG10/TCA1000; with Cr, Ni, pH, Bl, S.G.

Device Class : 2

Duns Number: 035967806

Premarket Exempt : No

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

Prescription Use : Yes

Device Count : 1

Intelligent Transport Cup - 00858886006292 Catalog Number : ITCA-12M-W

Device Description : Drugs of Abuse Test Cup for (BZO/BAR)+(COC/THC)+(MET/OPI2000)+(MTD/TCA)+(OXY/MDM Drugs of Abuse Test Cup for (BZO/BAR)+(COC/THC)+(MET/OPI2000)+(MTD/TCA)+(OXY/MDMA)+(PCP/AMP) with Cr, Ni, pH, Bl. S.G.

Device Class : 2

Duns Number: 035967806

Premarket Exempt : No

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

Prescription Use : Yes

Device Count : 1

Noble 1 Step Cup - 00858886006308 Catalog Number : NBCA-7C-W

Device Description : Drugs of Abuse Test Cup for (COC/THC)+(PCP/AMP)+BZO+OPI+OXY with Cr, Ni, pH, Bl, Drugs of Abuse Test Cup for (COC/THC)+(PCP/AMP)+BZO+OPI+OXY with Cr, Ni, pH, Bl, S.G. (CLIA Waived)

Device Class : 2

Duns Number: 035967806

Premarket Exempt : No

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

Prescription Use : Yes

Device Count : 1

Noble 1 Step Cup - 00858886006315 Catalog Number : NBCA-12M-W

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

Device Class : 2

Duns Number: 035967806

Premarket Exempt : No

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

Prescription Use : Yes

Device Count : 1

Noble 1 Step Cup - 00858886006322 Catalog Number : NBCA-14A-PP

Device Description : Drugs of Abuse Test Cup for THC50/C0C150/0PI300/mAMP500/AMP500/BZO300/BAR300/MTD Drugs of Abuse Test Cup for THC50/C0C150/0PI300/mAMP500/AMP500/BZO300/BAR300/MTD300/MDMA500/OXY100/BUP10/TCA1000/PPX300/PCP25 + (Creatinine/Ni/pH/B1/S.G.)

Device Class : 2

Duns Number: 035967806

Premarket Exempt : No

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

Prescription Use : Yes

Device Count : 1

Noble Dip Card (Urine) - 01085888600657 Catalog Number :

Device Description : AMP500/BAR300/BUP10/BZO300/COC150/MDMA500/MET500/MTD300/OPI300/OXY100/PCP25/THC50

Device Class : 2

Duns Number: 035967806

Premarket Exempt : No

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

Prescription Use : No

Device Count : 25

NOBLE - 10858886006008 Catalog Number :

Device Class :

Duns Number: 035967806

Premarket Exempt : No

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

Prescription Use : No

Device Count : 25

NOBLE - 10858886006015 Catalog Number :

Device Class :

Duns Number: 035967806

Premarket Exempt : No

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

Prescription Use : No

Device Count : 25

NOBLE - 10858886006022 Catalog Number :

Device Class :

Duns Number: 035967806

Premarket Exempt : No

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

Prescription Use : No

Device Count : 25

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