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FDA 510(k)

ID Now 仪器，ID Now 流感A & B 2，ID NOW 链球菌A 2

K号: K220801 · 2022-06-24

申请人Abbott Diagnostics Scarborough, Inc.
决定日期2022-06-24
产品代码OZE
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决定实质等同

器械摘要

ID Now Instrument, ID Now Influenza A & B 2, ID NOW Strep A 2 is the device name listed in this FDA 510(k) record. The listed applicant is Abbott Diagnostics Scarborough, Inc.. It received FDA 510(k) clearance on 2022-06-24 under 510(k) number K220801. 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 ID Now Instrument, ID Now Influenza A & B 2, ID NOW Strep A 2?

ID Now Instrument, ID Now Influenza A & B 2, ID NOW Strep A 2 is a medical device that received FDA 510(k) clearance on 2022-06-24. The listed applicant is Abbott Diagnostics Scarborough, Inc.. The 510(k) number is K220801.

When did ID Now Instrument, ID Now Influenza A & B 2, ID NOW Strep A 2 receive FDA 510(k) clearance?

ID Now Instrument, ID Now Influenza A & B 2, ID NOW Strep A 2 received FDA 510(k) clearance on 2022-06-24, under 510(k) number K220801.

Who is the listed applicant for ID Now Instrument, ID Now Influenza A & B 2, ID NOW Strep A 2?

FDA 510(k)记录将阿伯特诊断斯卡伯勒公司（Abbott Diagnostics Scarborough, Inc.）列为申请人。这本身并不能确立该设备制造商的身份。

What is the FDA product code for ID Now Instrument, ID Now Influenza A & B 2, ID NOW Strep A 2?

The FDA product code for ID Now Instrument, ID Now Influenza A & B 2, ID NOW Strep A 2 is OZE.

相关临床试验

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。

NCT07608549FLASHPilot 1期安全性研究NOT_YET_RECRUITINGNCT06562205PAP系统外部临床研究（ECS）NOT_YET_RECRUITINGNCT06443177交感神经调节对动脉瘤性蛛网膜下腔出血继发脑动脉痉挛的影响SUSPENDEDNCT07095751人工智能辅助尿路摄像头评估系统，用于诊断膀胱癌NOT_YET_RECRUITING

列明Abbott Diagnostics Scarborough, Inc.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。

K262747ID NOW 流感A & B 2；ID NOW RSV；ID NOW 链球菌A 2；ID NOW COVID-19 2.0K250273BinaxNOW COVID-19 Ag 卡K243518BinaxNOW® COVID-19 抗原自测K232775ID NOW 流感A & B 2K221925ID NOW COVID-19 2.0K191534ID NOW 流感A & B 2

查看所有 7 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 PreventionK243931CDC 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 PreventionK241110CDC 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 PreventionK230236Lyra A+B 流感病毒检测Quidel CorporationK200370CDC 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 PreventionK182513FluChip-8G Influenza A+B AssayIndevr, Inc.

官方来源

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