FDA 510(k)

奈諾檢流感+COVID-19雙重檢測

K 號：K243561 · 2025-06-17

決定日期2025-06-17

產品代碼SCA

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

Nano-Check Influenza+COVID-19 Dual Test is the device name listed in this FDA 510(k) record. The listed applicant is Nano-Ditech Corporation. It received FDA 510(k) clearance on 2025-06-17 under 510(k) number K243561. The device is classified under product code SCA. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Nano-Check Influenza+COVID-19 Dual Test?

Nano-Check Influenza+COVID-19 Dual Test is a medical device that received FDA 510(k) clearance on 2025-06-17. The listed applicant is Nano-Ditech Corporation. The 510(k) number is K243561.

When did Nano-Check Influenza+COVID-19 Dual Test receive FDA 510(k) clearance?

Nano-Check Influenza+COVID-19 Dual Test received FDA 510(k) clearance on 2025-06-17, under 510(k) number K243561.

Who is the listed applicant for Nano-Check Influenza+COVID-19 Dual Test?

The FDA 510(k) record lists Nano-Ditech Corporation as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Nano-Check Influenza+COVID-19 Dual Test?

The FDA product code for Nano-Check Influenza+COVID-19 Dual Test is SCA.

其他以 Nano-Ditech Corporation 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。

K252283奈諾檢流感A+B檢測試劑 K240280Nano-Check™ RSV測試 K231187Nano-Check™ COVID-19 抗原檢測

相關器械（代碼：SCA）

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。

K261212Flowflex Plus RSV + 流行性感冒A/B + COVID 快速檢測ACON Laboratories, Inc.K251092iHealth流感A&B/COVID-19快速檢測; iHealth流感A&B/COVID-19快速檢測ProIhealth Labs, Inc.K251085iHealth 流感A&B/COVID-19/RSV 快速檢測；iHealth 流感A&B/COVID-19/RSV 快速檢測 ProIhealth Labs, Inc.K251538Status™ COVID-19/流感A&BPrinceton BioMeditech Corp.K251749Flowflex Plus RSV + 流行性感冒A/B + COVID家庭檢測ACON Laboratories, Inc.K251604CareSuperb COVID-19/流感A&B抗原組合居家檢測Access Bio, Inc.

官方來源

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