FDA 510(k)

VIDAS TBI（GFAP，UCH-L1）

K号: K240279 · 2024-05-01

决定日期2024-05-01

产品代码QAT

咨询委员会抱歉，您提供的信息不完整，无法进行翻译。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

VIDAS TBI (GFAP, UCH-L1) is the device name listed in this FDA 510(k) record. The listed applicant is bioMerieux, Inc.. It received FDA 510(k) clearance on 2024-05-01 under 510(k) number K240279. The device is classified under product code QAT. It was reviewed by the IM advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the VIDAS TBI (GFAP, UCH-L1)?

VIDAS TBI (GFAP, UCH-L1) is a medical device that received FDA 510(k) clearance on 2024-05-01. The listed applicant is bioMerieux, Inc.. The 510(k) number is K240279.

When did VIDAS TBI (GFAP, UCH-L1) receive FDA 510(k) clearance?

VIDAS TBI (GFAP, UCH-L1) received FDA 510(k) clearance on 2024-05-01, under 510(k) number K240279.

Who is the listed applicant for VIDAS TBI (GFAP, UCH-L1)?

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

What is the FDA product code for VIDAS TBI (GFAP, UCH-L1)?

The FDA product code for VIDAS TBI (GFAP, UCH-L1) is QAT.

列明bioMerieux, 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。

K260160VITEK REVEAL GN AST 测定和 VITEK REVEAL AST 系统 K260282VITEK 2 AST-诱导克林霉素耐药性链球菌 K251579VITEK 2 AST-革兰氏阴性头孢唑啉（=<1-=>32 µg/mL）K234012VITEK COMPACT PRO K232967VITEK 2 AST-酵母伏立康唑（<= 0.03125 - >= 4 µg/mL）K232963VITEK 2 AST-酵母阿尼鲁兰（<= 0.015 - >= 8 µg/mL）

查看所有 65 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。