FDA 510(k)

CorDx Tyfast COVID-19 Ag 快速檢測藥品許可證

K 號：K253882 · 2026-06-01

決定日期2026-06-01

產品代碼QVF

諮詢委員會MI (請提供完整的描述文本，以便進行翻譯。)

決定相當於

器材摘要

CorDx Tyfast COVID-19 Ag Rapid Test Rx is the device name listed in this FDA 510(k) record. The listed applicant is CorDx, Inc.. It received FDA 510(k) clearance on 2026-06-01 under 510(k) number K253882. The device is classified under product code QVF. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the CorDx Tyfast COVID-19 Ag Rapid Test Rx?

CorDx Tyfast COVID-19 Ag Rapid Test Rx is a medical device that received FDA 510(k) clearance on 2026-06-01. The listed applicant is CorDx, Inc.. The 510(k) number is K253882.

When did CorDx Tyfast COVID-19 Ag Rapid Test Rx receive FDA 510(k) clearance?

CorDx Tyfast COVID-19 Ag Rapid Test Rx received FDA 510(k) clearance on 2026-06-01, under 510(k) number K253882.

Who is the listed applicant for CorDx Tyfast COVID-19 Ag Rapid Test Rx?

The FDA 510(k) record lists CorDx, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for CorDx Tyfast COVID-19 Ag Rapid Test Rx?

The FDA product code for CorDx Tyfast COVID-19 Ag Rapid Test Rx is QVF.

其他以 CorDx, Inc. 為申請人之記錄

相關紀錄係使用名稱、產品代碼或其他後設資料自動配對。配對結果並不構成已驗證的臨床、科學、企業或監管關係，請查閱連結的官方來源。

K240728CorDx Tyfast COVID-19 Ag 快速檢測；CorDx COVID-19 Ag 檢測

相關器械（代碼：QVF）

相關紀錄係使用名稱、產品代碼或其他後設資料自動配對。配對結果並不構成已驗證的臨床、科學、企業或監管關係，請查閱連結的官方來源。

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官方來源

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