FDA 510(k)

Alere BinaxNOW流感A & B卡2，Alere Reader

K号: K181853 · 2018-08-08

决定日期2018-08-08

产品代码PSZ

咨询委员会抱歉，您提供的内容“MI”不足以进行翻译。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

Alere BinaxNOW Influenza A & B Card 2, Alere Reader is the device name listed in this FDA 510(k) record. The listed applicant is Alere Scarborough, Inc.. It received FDA 510(k) clearance on 2018-08-08 under 510(k) number K181853. 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 Alere BinaxNOW Influenza A & B Card 2, Alere Reader?

Alere BinaxNOW Influenza A & B Card 2, Alere Reader is a medical device that received FDA 510(k) clearance on 2018-08-08. The listed applicant is Alere Scarborough, Inc.. The 510(k) number is K181853.

When did Alere BinaxNOW Influenza A & B Card 2, Alere Reader receive FDA 510(k) clearance?

Alere BinaxNOW Influenza A & B Card 2, Alere Reader received FDA 510(k) clearance on 2018-08-08, under 510(k) number K181853.

Who is the listed applicant for Alere BinaxNOW Influenza A & B Card 2, Alere Reader?

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

What is the FDA product code for Alere BinaxNOW Influenza A & B Card 2, Alere Reader?

The FDA product code for Alere BinaxNOW Influenza A & B Card 2, Alere Reader is PSZ.

列明Alere Scarborough, 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。

K190204ID NOW 流感A & B 2 K173653Alere i 链球菌A 2，Alere i 仪器，Alere i 链球菌A 2控制拭子套装 K173932Alere i 流感A & B，Alere i 链球菌A，Alere i RSV，Alere i 流感A & B 2 K173502Alere BinaxNOW流感A & B卡2，Alere Reader，Alere BinaxNOW流感A & B卡2控制拭子套装 K171792Alere i 流感A & B 2，Alere i 仪器，Alere i 流感A & B控制拭子套装 K162642Alere BinaxNOW流感A & B卡2，Alere Reader，Alere BinaxNOW流感A & B卡2控制拭子套装

查看所有 10 个设备 →

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 Corporation K250398Innovita Flu A/B Antigen Rapid TestInnovita (Tangshan) Biological Technology Co., Ltd.K241188Acucy®流感A&B测试与Acucy® 2系统SEKISUI Diagnostics, LLC K232434BD Veritor™ System for Rapid Detection of Flu A+B CLIA Waived KitBd K223016BD VeritorTM System for Rapid Detection of Flu A+B CLIA-Waived KitBd

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。