Genomadix™ Cube CYP2C19 System

Description

The Cube CYP2C19 System is an FDA 510(K)-cleared, sample-to-result DNA testing system with integrated DNA extraction and amplification.

• FDA 510(k)-cleared.
• The Genomadix Cube is a thermal cycling instrument that automatically integrates extraction of DNA from the buccal sample, PCR amplification and fluorescence-based detection of CYP2C19 alleles
• The computer is a consumer-grade netbook computer that serves as the user interface for logging into the platform, inputting patient information, starting the test, and genotype calling.
• The barcode scanner is used to scan test kit barcodes (used for recording lot and expiry information) and for scanning patient identifier barcodes.
• No maintenance or calibration required.

Specifications

• Clia Complexity: High
• Type: Genotyping System
• For Use With (Application): Determine an individual's CYP2C19 genotype in relation to the 2, 3 and 17 loci
• Form: Ready-to-Use (RTU)

FDA 510(K)-cleared