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FDA 510(k)

Innovita Flu A/B Antigen Rapid Test

K号: K250398 · 2025-07-03

申请人Innovita (Tangshan) Biological Technology Co., Ltd.
决定日期2025-07-03
产品代码PSZ
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决定实质等同

器械摘要

Innovita Flu A/B Antigen Rapid Test is the device name listed in this FDA 510(k) record. The listed applicant is Innovita (Tangshan) Biological Technology Co., Ltd.. It received FDA 510(k) clearance on 2025-07-03 under 510(k) number K250398. The device is classified under product code PSZ. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the Innovita Flu A/B Antigen Rapid Test?

Innovita Flu A/B Antigen Rapid Test is a medical device that received FDA 510(k) clearance on 2025-07-03. The listed applicant is Innovita (Tangshan) Biological Technology Co., Ltd.. The 510(k) number is K250398.

When did Innovita Flu A/B Antigen Rapid Test receive FDA 510(k) clearance?

Innovita Flu A/B Antigen Rapid Test received FDA 510(k) clearance on 2025-07-03, under 510(k) number K250398.

Who is the listed applicant for Innovita Flu A/B Antigen Rapid Test?

The FDA 510(k) record lists Innovita (Tangshan) Biological Technology Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Innovita Flu A/B Antigen Rapid Test?

The FDA product code for Innovita Flu A/B Antigen Rapid Test is PSZ.

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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Innovita (Tangshan) Biological Technology Co., Ltd.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。

K241919Innovita HCG Pregnancy Rapid Combo TestK192843INNOVITA HCG 孕检快速测试条，INNOVITA HCG 孕检快速测试卡，INNOVITA HCG 孕检快速测试中段

相关器械（代码：PSZ）

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。

K254262索菲亚流感A+B快速免疫分析；索菲亚呼吸道合胞病毒快速免疫分析；索菲亚链球菌A+快速免疫分析Ortho Clinical Diagnostics Inc. (QuidelOrtho)K252283Nano-Check流感A+B测试Nano-Ditech CorporationK241188Acucy®流感A&B测试与Acucy® 2系统SEKISUI Diagnostics, LLCK232434BD Veritor™ System for Rapid Detection of Flu A+B CLIA Waived KitBdK223016BD VeritorTM System for Rapid Detection of Flu A+B CLIA-Waived KitBdK192719Osom Ultra Plus 流感A&B测试套件SEKISUI Diagnostics, LLC

官方来源

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