酶联免疫吸附测定，丙型肝炎病毒
PMA编号：P010021 · 2020-08-07
广告
决定日期2020-08-07
PMA 编号P010021
产品代码MZO
设备分类第2类
医疗专科M
法规编号21 CFR 8
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。
器械摘要
Assay, enzyme linked immunosorbent, hepatitis c virus is the device name listed in this FDA 510(k) record. The listed applicant is Ortho-Clinical Diagnostics, Inc.. It received FDA 510(k) clearance on 2020-08-07. The device is classified under product code MZO. It was reviewed by the MI advisory panel.
常见问题
What is the Assay, enzyme linked immunosorbent, hepatitis c virus?
Assay, enzyme linked immunosorbent, hepatitis c virus is a medical device that received FDA 510(k) clearance on 2020-08-07. The listed applicant is Ortho-Clinical Diagnostics, Inc..
When did Assay, enzyme linked immunosorbent, hepatitis c virus receive FDA 510(k) clearance?
The clearance date for Assay, enzyme linked immunosorbent, hepatitis c virus can be found in the official FDA records.
Who is the listed applicant for Assay, enzyme linked immunosorbent, hepatitis c virus?
The FDA 510(k) record lists Ortho-Clinical Diagnostics, Inc. as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for Assay, enzyme linked immunosorbent, hepatitis c virus?
The FDA product code for Assay, enzyme linked immunosorbent, hepatitis c virus is MZO.
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。
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