巨细胞病毒（cmv）DNA定量检测
PMA编号：P130027 · 2018-09-26
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申请人Qiagen, Inc.
决定日期2018-09-26
PMA 编号P130027
产品代码PAB
设备分类第2类
医疗专科M
法规编号21 CFR 8
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器械摘要
Cytomegalovirus (cmv) dna quantitative assay is the device name listed in this FDA 510(k) record. The listed applicant is Qiagen, Inc.. It received FDA 510(k) clearance on 2018-09-26. The device is classified under product code PAB. It was reviewed by the MI advisory panel.
常见问题
What is the Cytomegalovirus (cmv) dna quantitative assay?
Cytomegalovirus (cmv) dna quantitative assay is a medical device that received FDA 510(k) clearance on 2018-09-26. The listed applicant is Qiagen, Inc..
When did Cytomegalovirus (cmv) dna quantitative assay receive FDA 510(k) clearance?
The clearance date for Cytomegalovirus (cmv) dna quantitative assay can be found in the official FDA records.
Who is the listed applicant for Cytomegalovirus (cmv) dna quantitative assay?
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 Cytomegalovirus (cmv) dna quantitative assay?
The FDA product code for Cytomegalovirus (cmv) dna quantitative assay is PAB.
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官方来源
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