FDA 510(k)

Simplexa 博德特菌直接检测，Simplexa 博德特菌阳性对照包

K号: K183223 · 2018-12-19

决定日期2018-12-19

产品代码OZZ

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

Simplexa Bordetella Direct, Simplexa Bordetella Positive Control Pack is the device name listed in this FDA 510(k) record. The listed applicant is Diasorin Molecular, LLC. It received FDA 510(k) clearance on 2018-12-19 under 510(k) number K183223. The device is classified under product code OZZ. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the Simplexa Bordetella Direct, Simplexa Bordetella Positive Control Pack?

Simplexa Bordetella Direct, Simplexa Bordetella Positive Control Pack is a medical device that received FDA 510(k) clearance on 2018-12-19. The listed applicant is Diasorin Molecular, LLC. The 510(k) number is K183223.

When did Simplexa Bordetella Direct, Simplexa Bordetella Positive Control Pack receive FDA 510(k) clearance?

Simplexa Bordetella Direct, Simplexa Bordetella Positive Control Pack received FDA 510(k) clearance on 2018-12-19, under 510(k) number K183223.

Who is the listed applicant for Simplexa Bordetella Direct, Simplexa Bordetella Positive Control Pack?

The FDA 510(k) record lists Diasorin Molecular, LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Simplexa Bordetella Direct, Simplexa Bordetella Positive Control Pack?

The FDA product code for Simplexa Bordetella Direct, Simplexa Bordetella Positive Control Pack is OZZ.

列明Diasorin Molecular, LLC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。

K260333LIAISON NES A组链球菌；LIAISON NES A组链球菌控制拭子套件 K251978LIAISON NES 流感A/B，RSV & COVID-19 K252387Simplexa® COVID-19/流感A/B & RSV 直接检测（MOL4450）；Simplexa® COVID-19/流感A/B & RSV 阳性对照包（MOL4460）K220963Simplexa COVID-19 & 流感 A/B 直接检测 K202755Simplexa 先天性巨细胞病毒直接检测和Simplexa 先天性巨细胞病毒阳性对照包 K212147Simplexa COVID-19 直接检测

查看所有 13 个设备 →

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。