Co-Diagnostics Announces FDA Submission Of Dual 510(k) With Concurrent CLIA Waiver Application For Co-Dx PCR Flu A/B & RSV Point-Of-Care Test
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Why It Matters
Co-Diagnostics sent paperwork to the FDA to sell a quick flu and RSV test that doctors can use right in their office. This is a step forward, but the FDA still needs to say yes before the test can actually be sold.
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