FDA 510(k)

聯繫 NES 集團 A 醜群；聯繫 NES 集團 A 醜群控制拭子套件

K 號：K260333 · 2026-06-15

決定日期2026-06-15

產品代碼PGX

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

LIAISON NES Group A Strep; LIAISON NES Group A Strep Control Swab Kit is the device name listed in this FDA 510(k) record. The listed applicant is Diasorin Molecular, LLC. It received FDA 510(k) clearance on 2026-06-15 under 510(k) number K260333. The device is classified under product code PGX. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the LIAISON NES Group A Strep; LIAISON NES Group A Strep Control Swab Kit?

LIAISON NES Group A Strep; LIAISON NES Group A Strep Control Swab Kit is a medical device that received FDA 510(k) clearance on 2026-06-15. The listed applicant is Diasorin Molecular, LLC. The 510(k) number is K260333.

When did LIAISON NES Group A Strep; LIAISON NES Group A Strep Control Swab Kit receive FDA 510(k) clearance?

LIAISON NES Group A Strep; LIAISON NES Group A Strep Control Swab Kit received FDA 510(k) clearance on 2026-06-15, under 510(k) number K260333.

Who is the listed applicant for LIAISON NES Group A Strep; LIAISON NES Group A Strep Control Swab Kit?

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

What is the FDA product code for LIAISON NES Group A Strep; LIAISON NES Group A Strep Control Swab Kit?

The FDA product code for LIAISON NES Group A Strep; LIAISON NES Group A Strep Control Swab Kit is PGX.

其他以 Diasorin Molecular, LLC 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。

K251978聯盟 NES 流感 A/B、RSV 及 COVID-19 K252387Simplexa™ COVID-19/流感A/B & RSV直接檢測儀（MOL4450）；Simplexa™ COVID-19/流感A/B & RSV陽性控制組裝（MOL4460）K220963簡易快篩COVID-19及流感A/B直測 K202755Simplexa先天性CMV直接檢測和Simplexa先天性CMV陽性控制組合包 K212147簡易快篩COVID-19直測 K201505Simplexa 流感A/B & RSV直接二代，Simplexa 流感A/B & RSV陽性控制組合包

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相關器械（代碼：PGX）

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。

K260047cobas Strep A 鈾酸測試，用於 cobas Liat 系統（07341911190）；cobas Strep A 質量控制套件（07402678190）Roche Molecular Systems, Inc.K201269Accula Strep A TestMesa Biotech, Inc.K183366基因POC 链球菌AGenepoc, Inc.K173653Alere i 链球菌A 2，Alere i儀器，Alere i 链球菌A 2控制拭子套件Alere Scarborough, Inc.K173398Xpert Xpress 醫療設備議定文 Xpert Xpress 醫療設備Cepheid K172402ARIES A 群鏈球菌試劑，ARIES A 群鏈球菌試劑實驗方案文件套件Luminex Corporation

官方來源

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