结核分枝杆菌，细胞介导的免疫反应，酶联免疫斑点试验
PMA编号：P070006 · 2025-08-04
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决定日期2025-08-04
PMA 编号P070006
产品代码OJN
设备分类第3类
医疗专科U
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器械摘要
Mycobacterium tuberculosis, Cell mediated immune response, enzyme-linked immunospot test is the device name listed in this FDA 510(k) record. The listed applicant is Oxford Immunotec, Ltd.. It received FDA 510(k) clearance on 2025-08-04. The device is classified under product code OJN. It was reviewed by the MI advisory panel.
常见问题
What is the Mycobacterium tuberculosis, Cell mediated immune response, enzyme-linked immunospot test?
Mycobacterium tuberculosis, Cell mediated immune response, enzyme-linked immunospot test is a medical device that received FDA 510(k) clearance on 2025-08-04. The listed applicant is Oxford Immunotec, Ltd..
When did Mycobacterium tuberculosis, Cell mediated immune response, enzyme-linked immunospot test receive FDA 510(k) clearance?
The clearance date for Mycobacterium tuberculosis, Cell mediated immune response, enzyme-linked immunospot test can be found in the official FDA records.
Who is the listed applicant for Mycobacterium tuberculosis, Cell mediated immune response, enzyme-linked immunospot test?
The FDA 510(k) record lists Oxford Immunotec, Ltd. as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for Mycobacterium tuberculosis, Cell mediated immune response, enzyme-linked immunospot test?
The FDA product code for Mycobacterium tuberculosis, Cell mediated immune response, enzyme-linked immunospot test is OJN.
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官方来源
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