SCoV-2 Ag Detect 快速检测
K号: K233358 · 2024-08-23
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决定日期2024-08-23
产品代码QVF
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器械摘要
SCoV-2 Ag Detect Rapid Test is the device name listed in this FDA 510(k) record. The listed applicant is InBios International, Inc.. It received FDA 510(k) clearance on 2024-08-23 under 510(k) number K233358. The device is classified under product code QVF. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.
常见问题
What is the SCoV-2 Ag Detect Rapid Test?
SCoV-2 Ag Detect Rapid Test is a medical device that received FDA 510(k) clearance on 2024-08-23. The listed applicant is InBios International, Inc.. The 510(k) number is K233358.
When did SCoV-2 Ag Detect Rapid Test receive FDA 510(k) clearance?
SCoV-2 Ag Detect Rapid Test received FDA 510(k) clearance on 2024-08-23, under 510(k) number K233358.
Who is the listed applicant for SCoV-2 Ag Detect Rapid Test?
The FDA 510(k) record lists InBios International, Inc. as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for SCoV-2 Ag Detect Rapid Test?
The FDA product code for SCoV-2 Ag Detect Rapid Test is QVF.
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列明InBios International, 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。
相关器械（代码：QVF）
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。
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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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