Spartan RX CYP2C19 System 01004777

GUDID 00628055420019

Spartan RX Analyzer

Spartan Bioscience Inc

Thermal cycler nucleic acid amplification analyser IVD, laboratory, semi-automated

• Primary Device ID: 00628055420019
• NIH Device Record Key: b1e03f91-3587-45cd-8f40-1d278ac7dc5a
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Spartan RX CYP2C19 System
• Version Model Number: 01004777
• Catalog Number: 01004777
• Company DUNS: 243605917
• Company Name: Spartan Bioscience Inc
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: false
• Serial Number: true
• Manufacturing Date: true
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00628055420019 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K123891

FDA Product Code

• NSU: Instrumentation For Clinical Multiplex Test Systems

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2016-09-26

On-Brand Devices [Spartan RX CYP2C19 System]

• 00628055420064: This is Box 1 of 3 of the Spartan RX CYP2C19 Platform. It contains the Spartan RX Analyzer (0100
• 00628055420101: A box of 20 SNP CYP2C19 External Control Kits.
• 00628055420095: A box of 10 CYP2C19 External Control Kits.
• 00628055420088: A box of 20 CYP2C19 Sample Collection Kits.
• 00628055420071: This is Box 2 of 3 for the Spartan RX CYP2C19 Platform. It contains the Spartan RX Netbook (0100
• 00628055420057: The Spartan RX Sample Transport System supplied with the Spartan RX CYP2C19 System. It includes:
• 00628055420040: Barcode Scanner supplied with the Spartan RX CYP2C19 System.
• 00628055420033: Printer supplied with the Spartan RX CYP2C19 System
• 00628055420026: Netbook supplied with the Spartan RX CYP2C19 System.
• 00628055420019: Spartan RX Analyzer