Why consider an FDA-cleared device for your genetic tests and molecular diagnostics

The Oragene™•Dx and ORAcollect™•Dx devices have US FDA 510(k) general clearance for prescription and over-the-counter (direct-to-consumer) uses. This designation allows this device to be used by commercial partners and legally marketed with their therapeutics or devices in conjunction with their product's intended use. Discover how an FDA-cleared device may offer advantages such as:

• Validated performance and ease of use
• Reduced timeline to validate your Laboratory Developed Assay (LDT)
• Cost-effective market path for your genetic test
• Reduced regulatory burden when filing an FDA submission for your assay
• Customization offerings for your test (branding and fulfillment services)