FDA 510(k)

BioPlex 2200 狸蟲病總量

K 號：K183446 · 2019-03-12

決定日期2019-03-12

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

BioPlex 2200 Lyme Total is the device name listed in this FDA 510(k) record. The listed applicant is Bio-Rad Laboratories. It received FDA 510(k) clearance on 2019-03-12 under 510(k) number K183446. 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 BioPlex 2200 Lyme Total?

BioPlex 2200 Lyme Total is a medical device that received FDA 510(k) clearance on 2019-03-12. The listed applicant is Bio-Rad Laboratories. The 510(k) number is K183446.

When did BioPlex 2200 Lyme Total receive FDA 510(k) clearance?

BioPlex 2200 Lyme Total received FDA 510(k) clearance on 2019-03-12, under 510(k) number K183446.

Who is the listed applicant for BioPlex 2200 Lyme Total?

The FDA 510(k) record lists Bio-Rad Laboratories as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for BioPlex 2200 Lyme Total?

The FDA product code for BioPlex 2200 Lyme Total is LSR.

其他以 Bio-Rad Laboratories 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。

K180577BioPlex 2200 25-OH 腫生素D 套件 K170509BioPlex 2200 ToRC IgM，BioPlex 2200 ToRC IgM校准組合包，BioPlex 2200 ToRC IgM控制組合包 K170413BioPlex 2200 梅毒總量及RPR，BioPlex 2200 梅毒總量及RPR 校正組合，BioPlex 2200 梅毒總量及RPR 控制組合 K163015Liquichek 癌症標記控制級別 1；Liquichek 癌症標記控制級別 2；Liquichek 癌症標記控制級別 3；Liquichek 癌症標記控制- 三級 MiniPak K152679Amplichek I, 負面, Amplichek I, 等級 1, Amplichek I, 等級 2, Amplichek I, 等級 3, Amplichek I, MiniPak

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.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

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