FDA 510(k)

CDC 人类流感病毒实时RT-PCR诊断试剂盒：流感B谱系基因分型试剂盒

K号: K181736 · 2018-07-30

申请人Centers For Disease Control and Prevention (CDC)

决定日期2018-07-30

产品代码OZE

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决定实质等同

器械摘要

CDC Human Influenza Virus Real-Time RT-PCR Diagnostic Panel: Influenza B Lineage Genotyping Kit, is the device name listed in this FDA 510(k) record. The listed applicant is Centers For Disease Control and Prevention (CDC). It received FDA 510(k) clearance on 2018-07-30 under 510(k) number K181736. 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 CDC Human Influenza Virus Real-Time RT-PCR Diagnostic Panel: Influenza B Lineage Genotyping Kit,?

CDC Human Influenza Virus Real-Time RT-PCR Diagnostic Panel: Influenza B Lineage Genotyping Kit, is a medical device that received FDA 510(k) clearance on 2018-07-30. The listed applicant is Centers For Disease Control and Prevention (CDC). The 510(k) number is K181736.

When did CDC Human Influenza Virus Real-Time RT-PCR Diagnostic Panel: Influenza B Lineage Genotyping Kit, receive FDA 510(k) clearance?

CDC Human Influenza Virus Real-Time RT-PCR Diagnostic Panel: Influenza B Lineage Genotyping Kit, received FDA 510(k) clearance on 2018-07-30, under 510(k) number K181736.

Who is the listed applicant for CDC Human Influenza Virus Real-Time RT-PCR Diagnostic Panel: Influenza B Lineage Genotyping Kit,?

The FDA 510(k) record lists Centers For Disease Control and Prevention (CDC) as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for CDC Human Influenza Virus Real-Time RT-PCR Diagnostic Panel: Influenza B Lineage Genotyping Kit,?

The FDA product code for CDC Human Influenza Virus Real-Time RT-PCR Diagnostic Panel: Influenza B Lineage Genotyping Kit, is OZE.

列明Centers For Disease Control and Prevention (CDC)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。

K170940立克次氏体实时PCR检测 K161556CDC 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

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 K230236Lyra A+B 流感病毒检测Quidel Corporation 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

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