检测预先存在的腺相关病毒（AAV）病毒载体抗体的测定
PMA编号：P250002 · 2025-07-24
广告
器械摘要
常见问题
What is the Assays to detect pre-existing antibodies to adeno-associated virus (AAV) viral vectors?
Assays to detect pre-existing antibodies to adeno-associated virus (AAV) viral vectors is a medical device that received FDA 510(k) clearance on 2025-07-24. The listed applicant is Quest Diagnostics Nichols Institute.
When did Assays to detect pre-existing antibodies to adeno-associated virus (AAV) viral vectors receive FDA 510(k) clearance?
The clearance date for Assays to detect pre-existing antibodies to adeno-associated virus (AAV) viral vectors can be found in the official FDA records.
Who is the listed applicant for Assays to detect pre-existing antibodies to adeno-associated virus (AAV) viral vectors?
The FDA 510(k) record lists Quest Diagnostics Nichols Institute as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for Assays to detect pre-existing antibodies to adeno-associated virus (AAV) viral vectors?
The FDA product code for Assays to detect pre-existing antibodies to adeno-associated virus (AAV) viral vectors is QWQ.
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