FDA 510(k)

Sofia 疥病FIA，Sofia 2分析仪，Sofia 2安装包

K号: K173691 · 2018-02-28

决定日期2018-02-28

产品代码LSR

咨询委员会抱歉，您提供的内容“MI”不足以进行翻译。请提供完整的医疗设备监管文本，以便我能够进行准确的翻译。

决定实质等同

器械摘要

Sofia Lyme FIA, Sofia 2 analyzer, Sofia 2 Installation Pack is the device name listed in this FDA 510(k) record. The listed applicant is Quidel Corporation. It received FDA 510(k) clearance on 2018-02-28 under 510(k) number K173691. The device is classified under product code LSR. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the Sofia Lyme FIA, Sofia 2 analyzer, Sofia 2 Installation Pack?

Sofia Lyme FIA, Sofia 2 analyzer, Sofia 2 Installation Pack is a medical device that received FDA 510(k) clearance on 2018-02-28. The listed applicant is Quidel Corporation. The 510(k) number is K173691.

When did Sofia Lyme FIA, Sofia 2 analyzer, Sofia 2 Installation Pack receive FDA 510(k) clearance?

Sofia Lyme FIA, Sofia 2 analyzer, Sofia 2 Installation Pack received FDA 510(k) clearance on 2018-02-28, under 510(k) number K173691.

Who is the listed applicant for Sofia Lyme FIA, Sofia 2 analyzer, Sofia 2 Installation Pack?

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

What is the FDA product code for Sofia Lyme FIA, Sofia 2 analyzer, Sofia 2 Installation Pack?

The FDA product code for Sofia Lyme FIA, Sofia 2 analyzer, Sofia 2 Installation Pack is LSR.

列明Quidel Corporation为申报人的其他记录

关联记录通过名称、产品代码或其他元数据自动匹配。匹配不意味着已验证临床、科学、企业或监管关系；请查阅链接的官方来源。

K231795QuickVue COVID-19 测试 K232286Savanna HSV 1+2/VZV 测定，Savanna HSV 1+2/VZV 控制套件，Savanna 仪器 K233688Sofia 2 SARS抗原+ FIA；Sofia 2 SARS抗原+ FIA控制拭子套装 K230349Lyra RSV+hMPV 检测 K230236Lyra A+B 流感病毒检测 K211342Sofia 2 营养性弧菌FIA

查看所有 22 个设备 →

相关器械（代码：LSR）

关联记录通过名称、产品代码或其他元数据自动匹配。匹配不意味着已验证临床、科学、企业或监管关系；请查阅链接的官方来源。

K254295Sofia Lyme FIA；Sofia 2 螺旋菌 FIAOrtho-Clinical Diagnostics, Inc. (QuidelOrtho)K252627Lyme-ID IgG 测试；Bio-ID800Inanovate, Inc.K242872iDart Lyme IgM ImmunoBlot KitId-Fish Technology, Inc.K233367iDart莱姆病IgG免疫印迹试剂盒Id-Fish Technology, Inc.K230863宙斯索利纳斯伯氏螺旋体VlsE1/pepC10 IgG/IgM检测系统；宙斯索利纳斯伯氏螺旋体VlsE1/pepC10 IgG/IgM对照试剂盒Zeus Scientific K220016Viramed Borrela 全合一 ViraChip 检测试剂盒Viramed Biotech AG

官方来源

在 FDA 数据库中查看 →

数据来源于FDA开放API。如需最新且权威的信息，请务必参考官方记录。