胎盘α微球蛋白-1免疫测定
PMA编号：P160052 · 2019-10-11
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申请人Qiagen, Inc.
决定日期2019-10-11
PMA 编号P160052
产品代码QBB
设备分类第3类
医疗专科U
咨询委员会TX
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器械摘要
Placental alpha microglobulin-1 immunoassay is the device name listed in this FDA 510(k) record. The listed applicant is Qiagen, Inc.. It received FDA 510(k) clearance on 2019-10-11. The device is classified under product code QBB. It was reviewed by the TX advisory panel.
常见问题
What is the Placental alpha microglobulin-1 immunoassay?
Placental alpha microglobulin-1 immunoassay is a medical device that received FDA 510(k) clearance on 2019-10-11. The listed applicant is Qiagen, Inc..
When did Placental alpha microglobulin-1 immunoassay receive FDA 510(k) clearance?
The clearance date for Placental alpha microglobulin-1 immunoassay can be found in the official FDA records.
Who is the listed applicant for Placental alpha microglobulin-1 immunoassay?
The FDA 510(k) record lists Qiagen, Inc. as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for Placental alpha microglobulin-1 immunoassay?
The FDA product code for Placental alpha microglobulin-1 immunoassay is QBB.
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官方来源
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