ASSAY，酶联免疫吸附，B19 帕尔沃病毒 IgM
PMA编号：P150042 · 2017-09-19
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决定日期2017-09-19
PMA 编号P150042
产品代码MYM
设备分类第3类
医疗专科U
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,ENZYME LINKED IMMUNOSORBENT,PARVOVIRUS B19 IGM is the device name listed in this FDA 510(k) record. The listed applicant is Zeus Scientific, Inc.. It received FDA 510(k) clearance on 2017-09-19. The device is classified under product code MYM. It was reviewed by the MI advisory panel.
常见问题
What is the ASSAY,ENZYME LINKED IMMUNOSORBENT,PARVOVIRUS B19 IGM?
ASSAY,ENZYME LINKED IMMUNOSORBENT,PARVOVIRUS B19 IGM is a medical device that received FDA 510(k) clearance on 2017-09-19. The listed applicant is Zeus Scientific, Inc..
When did ASSAY,ENZYME LINKED IMMUNOSORBENT,PARVOVIRUS B19 IGM receive FDA 510(k) clearance?
The clearance date for ASSAY,ENZYME LINKED IMMUNOSORBENT,PARVOVIRUS B19 IGM can be found in the official FDA records.
Who is the listed applicant for ASSAY,ENZYME LINKED IMMUNOSORBENT,PARVOVIRUS B19 IGM?
The FDA 510(k) record lists Zeus Scientific, Inc. as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for ASSAY,ENZYME LINKED IMMUNOSORBENT,PARVOVIRUS B19 IGM?
The FDA product code for ASSAY,ENZYME LINKED IMMUNOSORBENT,PARVOVIRUS B19 IGM is MYM.
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官方来源
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