FDA 510(k)

iDart Lyme IgM ImmunoBlot 套件

K 號：K242872 · 2025-06-12

決定日期2025-06-12

產品代碼LSR

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

iDart Lyme IgM ImmunoBlot Kit is the device name listed in this FDA 510(k) record. The listed applicant is Id-Fish Technology, Inc.. It received FDA 510(k) clearance on 2025-06-12 under 510(k) number K242872. The device is classified under product code LSR. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the iDart Lyme IgM ImmunoBlot Kit?

iDart Lyme IgM ImmunoBlot Kit is a medical device that received FDA 510(k) clearance on 2025-06-12. The listed applicant is Id-Fish Technology, Inc.. The 510(k) number is K242872.

When did iDart Lyme IgM ImmunoBlot Kit receive FDA 510(k) clearance?

iDart Lyme IgM ImmunoBlot Kit received FDA 510(k) clearance on 2025-06-12, under 510(k) number K242872.

Who is the listed applicant for iDart Lyme IgM ImmunoBlot Kit?

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

What is the FDA product code for iDart Lyme IgM ImmunoBlot Kit?

The FDA product code for iDart Lyme IgM ImmunoBlot Kit is LSR.

其他以 Id-Fish Technology, 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。

K233367iDart Lyme IgG 免疫Blot 套件

相關器械（代碼：LSR）

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。

K254295索菲亞萊姆FIA；索菲亞2攝氏菌FIAOrtho-Clinical Diagnostics, Inc. (QuidelOrtho)K252627Lyme-ID IgG測試；Bio-ID800Inanovate, Inc.K233367iDart Lyme IgG 免疫Blot 套件Id-Fish Technology, Inc.K230863ZEUS Solinas Borrelia VlsE1/pepC10 IgG/IgM 測試系統；ZEUS Solinas Borrelia VlsE1/pepC10 IgG/IgM 控制組合Zeus Scientific K220016維拉美德 Borrela 全功能 ViraChip 檢測套件Viramed Biotech AG K203292Gold Standard Diagnostics 摩氏疏螺旋體IgG/IgM ELISA檢測套件Gold Standard Diagnostics

官方來源

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