FDA 510(k)

Borrelia B31 ViraChip IgM 测试套件

K号: K163695 · 2017-08-22

决定日期2017-08-22

产品代码LSR

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决定实质等同

器械摘要

Borrelia B31 ViraChip IgM Test Kit is the device name listed in this FDA 510(k) record. The listed applicant is Viramed Biotech AG. It received FDA 510(k) clearance on 2017-08-22 under 510(k) number K163695. 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 Borrelia B31 ViraChip IgM Test Kit?

Borrelia B31 ViraChip IgM Test Kit is a medical device that received FDA 510(k) clearance on 2017-08-22. The listed applicant is Viramed Biotech AG. The 510(k) number is K163695.

When did Borrelia B31 ViraChip IgM Test Kit receive FDA 510(k) clearance?

Borrelia B31 ViraChip IgM Test Kit received FDA 510(k) clearance on 2017-08-22, under 510(k) number K163695.

Who is the listed applicant for Borrelia B31 ViraChip IgM Test Kit?

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

What is the FDA product code for Borrelia B31 ViraChip IgM Test Kit?

The FDA product code for Borrelia B31 ViraChip IgM Test Kit is LSR.

列明Viramed Biotech AG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。

K220016Viramed Borrela 全合一 ViraChip 检测试剂盒 K163504Borrelia B31 ViraChip IgG 测试套件

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

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