Spartan Bioscience 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

Drug Metabolizing Enzyme Genotyping Systems (NTI) (10) Instrumentation For Clinical Multiplex Test Systems (NSU) (10)

Premarket Exempt

Clear

Spartan RX CYP2C19 System - 00628055420019 Catalog Number : 01004777

Device Description : Spartan RX Analyzer

Device Class : 2

Duns Number: 243605917

Premarket Exempt : No

Product Code : NSU, NTI

Prescription Use : Yes

Device Count : 1

Spartan RX CYP2C19 System - 00628055420026 Catalog Number : 01003214

Device Description : Netbook supplied with the Spartan RX CYP2C19 System.

Device Class : 2

Duns Number: 243605917

Premarket Exempt : No

Product Code : NSU, NTI

Prescription Use : Yes

Device Count : 1

Spartan RX CYP2C19 System - 00628055420033 Catalog Number : 01003438

Device Description : Printer supplied with the Spartan RX CYP2C19 System

Device Class : 2

Duns Number: 243605917

Premarket Exempt : No

Product Code : NSU, NTI

Prescription Use : Yes

Device Count : 1

Spartan RX CYP2C19 System - 00628055420040 Catalog Number : 01003359

Device Description : Barcode Scanner supplied with the Spartan RX CYP2C19 System.

Device Class : 2

Duns Number: 243605917

Premarket Exempt : No

Product Code : NSU, NTI

Prescription Use : Yes

Device Count : 1

Spartan RX CYP2C19 System - 00628055420057 Catalog Number : 01003374, 01003372, and 01003373

Device Description : The Spartan RX Sample Transport System supplied with the Spartan RX CYP2C19 Syst

Device Class : 2

Duns Number: 243605917

Premarket Exempt : No

Product Code : NSU, NTI

Prescription Use : Yes

Device Count : 1

Spartan RX CYP2C19 System - 00628055420064 Catalog Number : 01004985

Device Description : This is Box 1 of 3 of the Spartan RX CYP2C19 Platform. It contains the Spartan R

Device Class : 2

Duns Number: 243605917

Premarket Exempt : No

Product Code : NSU, NTI

Prescription Use : Yes

Device Count : 1

Spartan RX CYP2C19 System - 00628055420071 Catalog Number : 01004985

Device Description : This is Box 2 of 3 for the Spartan RX CYP2C19 Platform. It contains the Spartan

Device Class : 2

Duns Number: 243605917

Premarket Exempt : No

Product Code : NSU, NTI

Prescription Use : Yes

Device Count : 1

Spartan RX CYP2C19 System - 00628055420088 Catalog Number : 01004872-ABC

Device Description : A box of 20 CYP2C19 Sample Collection Kits.

Device Class : 2

Duns Number: 243605917

Premarket Exempt : No

Product Code : NSU, NTI

Prescription Use : Yes

Device Count : 1

Spartan RX CYP2C19 System - 00628055420095 Catalog Number : 01004880-ABC (10)

Device Description : A box of 10 CYP2C19 External Control Kits.

Device Class : 2

Duns Number: 243605917

Premarket Exempt : No

Product Code : NSU, NTI

Prescription Use : Yes

Device Count : 1

Spartan RX CYP2C19 System - 00628055420101 Catalog Number : 01004880-ABC (20)

Device Description : A box of 20 SNP CYP2C19 External Control Kits.

Device Class : 2

Duns Number: 243605917

Premarket Exempt : No

Product Code : NSU, NTI

Prescription Use : Yes

Device Count : 1

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