FDA 510(k)

奈諾檢流感A+B檢測試劑

K 號：K252283 · 2026-01-15

決定日期2026-01-15

產品代碼PSZ

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 A+B 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 2026-01-15 under 510(k) number K252283. The device is classified under product code PSZ. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Nano-Check Influenza A+B Test?

Nano-Check Influenza A+B Test is a medical device that received FDA 510(k) clearance on 2026-01-15. The listed applicant is Nano-Ditech Corporation. The 510(k) number is K252283.

When did Nano-Check Influenza A+B Test receive FDA 510(k) clearance?

Nano-Check Influenza A+B Test received FDA 510(k) clearance on 2026-01-15, under 510(k) number K252283.

Who is the listed applicant for Nano-Check Influenza A+B 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 A+B Test?

The FDA product code for Nano-Check Influenza A+B Test is PSZ.

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。

K243561奈諾檢流感+COVID-19雙重檢測 K240280Nano-Check™ RSV測試 K231187Nano-Check™ COVID-19 抗原檢測

相關器械（代碼：PSZ）

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。

K254262索菲亞流感A+B FIA；索菲亞呼吸道合胞病毒FIA；索菲亞溶血性链球菌A+ FIAOrtho Clinical Diagnostics Inc. (QuidelOrtho)K250398Innovita 流感A/B 抗原快速檢測Innovita (Tangshan) Biological Technology Co., Ltd.K241188Acucy® 開放性流感 A&B 檢測與 Acucy® 2 系統SEKISUI Diagnostics, LLC K232434BD Veritor™ 系統快速檢測流感A+B CLIA Waived KitBd K223016BD Veritor™ 系統快速檢測流感A+B CLIA-Waived KitBd K192719Osom Ultra Plus 流感A&B檢測套件SEKISUI Diagnostics, LLC

官方來源

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