FDA 510(k)

NxTAG呼吸道病原体检测板v2 (NxTAG RPP v2)

K号: K231758 · 2024-03-11

决定日期2024-03-11

产品代码QOF

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决定实质等同

器械摘要

NxTAG Respiratory Pathogen Panel v2 (NxTAG RPP v2) is the device name listed in this FDA 510(k) record. The listed applicant is Luminex Molecular Diagnostics, Inc.. It received FDA 510(k) clearance on 2024-03-11 under 510(k) number K231758. The device is classified under product code QOF. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the NxTAG Respiratory Pathogen Panel v2 (NxTAG RPP v2)?

NxTAG Respiratory Pathogen Panel v2 (NxTAG RPP v2) is a medical device that received FDA 510(k) clearance on 2024-03-11. The listed applicant is Luminex Molecular Diagnostics, Inc.. The 510(k) number is K231758.

When did NxTAG Respiratory Pathogen Panel v2 (NxTAG RPP v2) receive FDA 510(k) clearance?

NxTAG Respiratory Pathogen Panel v2 (NxTAG RPP v2) received FDA 510(k) clearance on 2024-03-11, under 510(k) number K231758.

Who is the listed applicant for NxTAG Respiratory Pathogen Panel v2 (NxTAG RPP v2)?

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

What is the FDA product code for NxTAG Respiratory Pathogen Panel v2 (NxTAG RPP v2)?

The FDA product code for NxTAG Respiratory Pathogen Panel v2 (NxTAG RPP v2) is QOF.

列明Luminex Molecular Diagnostics, 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。

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