Spartan RX CYP2C19 System

Basic Information

• Brand Name: Spartan RX CYP2C19 System
• Primary DI: 00628055420088
• Version / Model: 01004872-ABC
• Catalog Number: 01004872-ABC
• Company Name: Spartan Bioscience Inc
• Labeler DUNS: 243605917
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-09-26
• Public Version: 3
• Public Version Date: 2018-07-06
• Public Version Status: Update
• Public Device Record Key: c0617d27-a770-4d77-bf27-7add29bf397e

Device Description

A box of 20 CYP2C19 Sample Collection Kits.

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: Yes
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
NSU	Instrumentation For Clinical Multiplex Test Systems	Clinical Chemistry	862.2570	2
NTI	Drug Metabolizing Enzyme Genotyping Systems	Clinical Toxicology	862.3360	2

GMDN Terms

Code	Name	Definition	Implantable	Status
60091	Nucleic acid amplification mastermix kit IVD	A collection of reagents and other associated materials intended to be used in combination with sequence-specific primers, probes and/or controls to facilitate the amplification of a target nucleic acid sequence [i.e., deoxyribonucleic acid (DNA) or ribonucleic acid (RNA)} in a clinical specimen, using a nucleic acid amplification technique (e.g., polymerase chain reaction (PCR), loop-mediated isothermal amplification (LAMP)].	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00628055420088	GS1

Premarket Submissions

Submission Number	Supplement Number
K123891	000