基因分型测定，丙型肝炎病毒
PMA编号：P120012 · 2021-03-05
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决定日期2021-03-05
PMA 编号P120012
产品代码OBF
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, genotyping, hepatitis c virus is the device name listed in this FDA 510(k) record. The listed applicant is Abbott Molecular. It received FDA 510(k) clearance on 2021-03-05. The device is classified under product code OBF. It was reviewed by the MI advisory panel.
常见问题
What is the Assay, genotyping, hepatitis c virus?
Assay, genotyping, hepatitis c virus is a medical device that received FDA 510(k) clearance on 2021-03-05. The listed applicant is Abbott Molecular.
When did Assay, genotyping, hepatitis c virus receive FDA 510(k) clearance?
The clearance date for Assay, genotyping, hepatitis c virus can be found in the official FDA records.
Who is the listed applicant for Assay, genotyping, hepatitis c virus?
The FDA 510(k) record lists Abbott Molecular as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for Assay, genotyping, hepatitis c virus?
The FDA product code for Assay, genotyping, hepatitis c virus is OBF.
相关临床试验
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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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