FDA 510(k)

Lyme-ID IgG測試；Bio-ID800

K 號：K252627 · 2025-11-14

決定日期2025-11-14

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

Lyme-ID IgG Test; Bio-ID800 is the device name listed in this FDA 510(k) record. The listed applicant is Inanovate, Inc.. It received FDA 510(k) clearance on 2025-11-14 under 510(k) number K252627. 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 Lyme-ID IgG Test; Bio-ID800?

Lyme-ID IgG Test; Bio-ID800 is a medical device that received FDA 510(k) clearance on 2025-11-14. The listed applicant is Inanovate, Inc.. The 510(k) number is K252627.

When did Lyme-ID IgG Test; Bio-ID800 receive FDA 510(k) clearance?

Lyme-ID IgG Test; Bio-ID800 received FDA 510(k) clearance on 2025-11-14, under 510(k) number K252627.

Who is the listed applicant for Lyme-ID IgG Test; Bio-ID800?

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

What is the FDA product code for Lyme-ID IgG Test; Bio-ID800?

The FDA product code for Lyme-ID IgG Test; Bio-ID800 is LSR.

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)K242872iDart Lyme IgM ImmunoBlot 套件Id-Fish Technology, 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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