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FDA PMA

TEST, 免疫,细胞介导,结核分枝杆菌

PMA编号:P180047 · 2026-09-24

决定日期2026-09-24
PMA 编号P180047
产品代码NCD
设备分类第3类
医疗专科U
咨询委员会MI

器械摘要

TEST, IMMUNITY, CELL MEDIATED, MYCOBACTERIUM TUBERCULOSIS is the device name listed in this FDA 510(k) record. The listed applicant is DiaSorin, Inc.. It received FDA 510(k) clearance on 2026-09-24. The device is classified under product code NCD. It was reviewed by the MI advisory panel.

常见问题

What is the TEST, IMMUNITY, CELL MEDIATED, MYCOBACTERIUM TUBERCULOSIS?

TEST, IMMUNITY, CELL MEDIATED, MYCOBACTERIUM TUBERCULOSIS is a medical device that received FDA 510(k) clearance on 2026-09-24. The listed applicant is DiaSorin, Inc..

When did TEST, IMMUNITY, CELL MEDIATED, MYCOBACTERIUM TUBERCULOSIS receive FDA 510(k) clearance?

The clearance date for TEST, IMMUNITY, CELL MEDIATED, MYCOBACTERIUM TUBERCULOSIS can be found in the official FDA records.

Who is the listed applicant for TEST, IMMUNITY, CELL MEDIATED, MYCOBACTERIUM TUBERCULOSIS?

The FDA 510(k) record lists DiaSorin, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for TEST, IMMUNITY, CELL MEDIATED, MYCOBACTERIUM TUBERCULOSIS?

The FDA product code for TEST, IMMUNITY, CELL MEDIATED, MYCOBACTERIUM TUBERCULOSIS is NCD.

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