---
title: "Co-Diagnostics submits FDA 510(k) for Co-Dx PCR Flu A/B & RSV point-of-care test"
type: "News"
locale: "en"
url: "https://longbridge.com/en/news/296236160.md"
description: "Co-Diagnostics has submitted a 510(k) premarket notification to the FDA for its Co-Dx PCR Flu A/B & RSV upper-respiratory multiplex test. The filing pertains to use on the Co-Dx PCR Pro instrument, which is part of the company's point-of-care PCR platform aimed at a potential US launch."
datetime: "2026-08-18T13:30:32.000Z"
locales:
  - [zh-CN](https://longbridge.com/zh-CN/news/296236160.md)
  - [en](https://longbridge.com/en/news/296236160.md)
  - [zh-HK](https://longbridge.com/zh-HK/news/296236160.md)
generator: "portal-rs"
---

# Co-Diagnostics submits FDA 510(k) for Co-Dx PCR Flu A/B & RSV point-of-care test

-   Co-Diagnostics submitted a 510(k) premarket notification to the FDA for its Co-Dx PCR Flu A/B & RSV upper-respiratory multiplex test. \* Filing covers use on the Co-Dx PCR Pro instrument, part of its point-of-care PCR platform targeted for a potential US launch. Disclaimer: This news brief was created by Public Technologies (PUBT) using generative artificial intelligence. While PUBT strives to provide accurate and timely information, this AI-generated content is for informational purposes only and should not be interpreted as financial, investment, or legal advice. Co-Diagnostics Inc. published the original content used to generate this news brief via PR Newswire (Ref. ID: 202608180930PR\_NEWS\_USPR\_\_\_\_\_LA28476) on August 18, 2026, and is solely responsible for the information contained therein. © Copyright 2026 - Public Technologies (PUBT)

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> **Disclaimer: This article is for reference only and does not constitute any investment advice.**