Respiratory Test Kit ID NOW™ COVID-19 2.0 15 X 24 Tests CLIA Waived

Features

• ID NOW Promotion: (15) COVID-19 2.0 Kits (427000) + (2) each ID NOW instrument (NAT024)
• FDA-cleared ID NOW™ COVID-19 2.0 detects SARS-CoV-2 in 6–12 minutes with the option to add on the ID NOW™ Influenza A & B 2 test without collecting another sample
• Product ships with minimum 30 days dating
• Each COVID-19 2.0 Kit contains: (24) Test Bases, (24) Sample Receivers, (24) Transfer Cartridges, (24) Nasal Swabs, Positive and Negative Control Swabs, Product Insert and Quick Reference Instructions
• The ID NOW platform uses isothermal technology to provide molecular results faster than PCR for more timely and informed clincial decisions
• CLIA-waived; requires minimum training with easy on-screen video-guided operation and no manual pipetting required
• ID NOW™ Platform gives you the power to decide which tests to run based on patient presentation, circulating prevalence and seasonality of infectious diseases
• Easily add on Flu A & B testing based on clinical necessity, supporting diagnostic stewardship
• Diagnostic Stewardship: Right tests at the right time for optimal care and fewer unnecessary tests
• Unique ID NOW™ Instrument isothermal nucleic acid amplification technology provides molecular results in just minutes, allowing you to make effective clinical decisions sooner
• A key new feature of the ID NOW COVID-19 510(k) product and the supporting software update v7.1 provides customers with the flexibility to use a new sequential testing workflow; the sequential workflow will allow customers to have the option to add-on an ID NOW Influenza A & B 2 test after a COVID-19 result is received, using the same patient sample
• The new sequential testing workflow feature and the updated 510(k) labeling will apply to existing ID NOW COVID-19 2.0 EUA product after upgrading to software update v7.1; by performing this software update, it enables the sequential workflow for any ID NOW COVID-19 2.0 EUA product you may have in inventory

More Information

• ID NOW COVID-19 2.0 510k IFU
• ID NOW COVID-19 2.0 510k Assay Launch Tech Brief