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FDA 510(k)

ADVIA Centaur EBV-EBNA IgG

K号: K233605 · 2024-08-07

申请人Biokit, S.A.
决定日期2024-08-07
产品代码LLM
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决定实质等同

器械摘要

ADVIA Centaur EBV-EBNA 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 2024-08-07 under 510(k) number K233605. The device is classified under product code LLM. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the ADVIA Centaur EBV-EBNA IgG?

ADVIA Centaur EBV-EBNA IgG is a medical device that received FDA 510(k) clearance on 2024-08-07. The listed applicant is Biokit, S.A.. The 510(k) number is K233605.

When did ADVIA Centaur EBV-EBNA IgG receive FDA 510(k) clearance?

ADVIA Centaur EBV-EBNA IgG received FDA 510(k) clearance on 2024-08-07, under 510(k) number K233605.

Who is the listed applicant for ADVIA Centaur EBV-EBNA 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 EBV-EBNA IgG?

The FDA product code for ADVIA Centaur EBV-EBNA IgG is LLM.

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 IgMK213987ARCHITECT HSV-1 IgG，ARCHITECT HSV-1 IgG校准器，ARCHITECT HSV-1 IgG控制品K214068Quantia IgEK181333ADVIA Centaur 单纯疱疹病毒1型IgGK181334ADVIA Centaur 单纯疱疹病毒2型IgG

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官方来源

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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。

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