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FDA 510(k)

Simplexa 流感 A/B & RSV 直接检测 II代，Simplexa 流感 A/B & RSV 阳性对照包

K号: K201505 · 2020-08-22

申请人Diasorin Molecular, LLC
决定日期2020-08-22
产品代码OCC
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决定实质等同

器械摘要

Simplexa Flu A/B & RSV Direct Gen II, Simplexa Flu A/B & RSV Positive Control Pack is the device name listed in this FDA 510(k) record. The listed applicant is Diasorin Molecular, LLC. It received FDA 510(k) clearance on 2020-08-22 under 510(k) number K201505. The device is classified under product code OCC. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the Simplexa Flu A/B & RSV Direct Gen II, Simplexa Flu A/B & RSV Positive Control Pack?

Simplexa Flu A/B & RSV Direct Gen II, Simplexa Flu A/B & RSV Positive Control Pack is a medical device that received FDA 510(k) clearance on 2020-08-22. The listed applicant is Diasorin Molecular, LLC. The 510(k) number is K201505.

When did Simplexa Flu A/B & RSV Direct Gen II, Simplexa Flu A/B & RSV Positive Control Pack receive FDA 510(k) clearance?

Simplexa Flu A/B & RSV Direct Gen II, Simplexa Flu A/B & RSV Positive Control Pack received FDA 510(k) clearance on 2020-08-22, under 510(k) number K201505.

Who is the listed applicant for Simplexa Flu A/B & RSV Direct Gen II, Simplexa Flu A/B & RSV Positive Control Pack?

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

What is the FDA product code for Simplexa Flu A/B & RSV Direct Gen II, Simplexa Flu A/B & RSV Positive Control Pack?

The FDA product code for Simplexa Flu A/B & RSV Direct Gen II, Simplexa Flu A/B & RSV Positive Control Pack is OCC.

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Diasorin Molecular, LLC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。

K260333LIAISON NES A组链球菌；LIAISON NES A组链球菌控制拭子套件K251978LIAISON NES 流感A/B，RSV & COVID-19K252387Simplexa® COVID-19/流感A/B & RSV 直接检测（MOL4450）；Simplexa® COVID-19/流感A/B & RSV 阳性对照包（MOL4460）K220963Simplexa COVID-19 & 流感 A/B 直接检测K202755Simplexa 先天性巨细胞病毒直接检测和Simplexa 先天性巨细胞病毒阳性对照包K212147Simplexa COVID-19 直接检测

查看所有 13 个设备 →

相关器械（代码：OCC）

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。

K262747ID NOW 流感A & B 2；ID NOW RSV；ID NOW 链球菌A 2；ID NOW COVID-19 2.0Abbott Diagnostics Scarborough, Inc.K254139BioCode® 呼吸道病原体检测板 (RPP)Applied BioCode, Inc.K242613NxTAG®呼吸道病原体检测板Luminex Molecular Diagnostics, Inc.K232775ID NOW 流感A & B 2Abbott Diagnostics Scarborough, Inc.K231017Panther Fusion AdV/hMPV/RV AssayHologic, Inc.K213822cobas流感A/B & RSV核酸检测，适用于cobas Liat系统Roche Molecular Systems, Inc.

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。

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