FDA 510(k)

Lyra A+B 流感病毒检测

K号: K230236 · 2023-03-03

决定日期2023-03-03

产品代码OZE

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决定实质等同

器械摘要

Lyra Influenza A+B Assay is the device name listed in this FDA 510(k) record. The listed applicant is Quidel Corporation. It received FDA 510(k) clearance on 2023-03-03 under 510(k) number K230236. The device is classified under product code OZE. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the Lyra Influenza A+B Assay?

Lyra Influenza A+B Assay is a medical device that received FDA 510(k) clearance on 2023-03-03. The listed applicant is Quidel Corporation. The 510(k) number is K230236.

When did Lyra Influenza A+B Assay receive FDA 510(k) clearance?

Lyra Influenza A+B Assay received FDA 510(k) clearance on 2023-03-03, under 510(k) number K230236.

Who is the listed applicant for Lyra Influenza A+B Assay?

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 Lyra Influenza A+B Assay?

The FDA product code for Lyra Influenza A+B Assay is OZE.

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 K211342Sofia 2 营养性弧菌FIA K173496Sofia 2 疥病FIA，Sofia疥病控制套装

查看所有 22 个设备 →

相关器械（代码：OZE）

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。

K243274CDC 人类流感病毒实时RT-PCR诊断试剂盒：流感A/B分型试剂盒（VER 2）；流感A亚型鉴定试剂盒（VER 4）；流感B基因分型试剂盒（VER 1.1和2）；以及流感A/H5亚型鉴定试剂盒（VER 4）Centers for Disease Control and Prevention K243931CDC 人类流感病毒实时RT-PCR诊断试剂盒：流感A/B分型试剂盒（VER 2）；流感A亚型鉴定试剂盒（VER 4）；流感B谱系基因分型试剂盒（VER 1.1和2）；以及流感A/H5亚型鉴定试剂盒（VER 4）Centers for Disease Control and Prevention K241110CDC 人类流感病毒实时RT-PCR诊断试剂盒，流感A亚型鉴定试剂盒（Ver4）Centers for Disease Control and Prevention K220801ID Now 仪器，ID Now 流感A & B 2，ID NOW 链球菌A 2Abbott Diagnostics Scarborough, Inc.K200370CDC 人类流感病毒实时RT-PCR诊断试剂盒，流感A/B分型试剂盒，CDC 人类流感病毒实时RT-PCR诊断试剂盒，流感A亚型鉴定试剂盒，CDC 人类流感病毒实时RT-PCR，流感A/H5亚型鉴定试剂盒Centers for Disease Control and Prevention K182513FluChip-8G Influenza A+B AssayIndevr, Inc.

官方来源

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