FDA 510(k)

ADVIA Centaur 单纯疱疹病毒2型IgG

K号: K181334 · 2018-08-23

决定日期2018-08-23

产品代码MYF

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决定实质等同

器械摘要

ADVIA Centaur Herpes-2 IgG is the device name listed in this FDA 510(k) record. The listed applicant is Biokit, S.A.. It received FDA 510(k) clearance on 2018-08-23 under 510(k) number K181334. The device is classified under product code MYF. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the ADVIA Centaur Herpes-2 IgG?

ADVIA Centaur Herpes-2 IgG is a medical device that received FDA 510(k) clearance on 2018-08-23. The listed applicant is Biokit, S.A.. The 510(k) number is K181334.

When did ADVIA Centaur Herpes-2 IgG receive FDA 510(k) clearance?

ADVIA Centaur Herpes-2 IgG received FDA 510(k) clearance on 2018-08-23, under 510(k) number K181334.

Who is the listed applicant for ADVIA Centaur Herpes-2 IgG?

The FDA 510(k) record lists Biokit, S.A. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ADVIA Centaur Herpes-2 IgG?

The FDA product code for ADVIA Centaur Herpes-2 IgG is MYF.

列明Biokit, S.A.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。

K243575ARCHITECT HSV-2 IgG，ARCHITECT HSV-2 IgG校准器，ARCHITECT HSV-2 IgG控制品 K233606ADVIA Centaur EBV-VCA IgM K233605ADVIA Centaur EBV-EBNA IgG K213987ARCHITECT HSV-1 IgG，ARCHITECT HSV-1 IgG校准器，ARCHITECT HSV-1 IgG控制品 K214068Quantia IgE K181333ADVIA Centaur 单纯疱疹病毒1型IgG

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官方来源

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