QIAstat-Dx 呼吸系统检测板
K号: K183597 · 2019-05-18
广告
器械摘要
QIAstat-Dx Respiratory Panel is the device name listed in this FDA 510(k) record. The listed applicant is QIAGEN GmbH. It received FDA 510(k) clearance on 2019-05-18 under 510(k) number K183597. 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 QIAstat-Dx Respiratory Panel?
QIAstat-Dx Respiratory Panel is a medical device that received FDA 510(k) clearance on 2019-05-18. The listed applicant is QIAGEN GmbH. The 510(k) number is K183597.
When did QIAstat-Dx Respiratory Panel receive FDA 510(k) clearance?
QIAstat-Dx Respiratory Panel received FDA 510(k) clearance on 2019-05-18, under 510(k) number K183597.
Who is the listed applicant for QIAstat-Dx Respiratory Panel?
FDA 510(k)记录显示QIAGEN GmbH为申请人。这本身并不能确立该设备的制造商。
What is the FDA product code for QIAstat-Dx Respiratory Panel?
The FDA product code for QIAstat-Dx Respiratory Panel 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。
列明QIAGEN GmbH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。
K262168QIAstat-Dx BCID GN Plus 抗生素耐药性检测板K254194QIAstat-Dx BCID GPF Plus 抗生素耐药性检测板K254032QIAstat-Dx 胃肠道检测板 2；QIAstat-Dx GI Panel 2 Mini B&V；QIAstat-Dx GI Panel 2 Mini BK252329QIAstat-Dx 胃肠道检测板 2；QIAstat-Dx GI Panel 2 Mini B&V；QIAstat-Dx GI Panel 2 Mini BK250080QIAstat-Dx 呼吸系统检测板 Plus；QIAstat-Dx 呼吸系统检测板 MiniK250324QIAstat-Dx GI Panel 2 Mini B
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。
广告