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FDA PMA

TEST, IMMUNITY, CELL MEDIATED, MYCOBACTERIUM TUBERCULOSIS

PMA 核准號:P180047 · 2026-09-24

決定日期2026-09-24
PMA 編號P180047
產品代碼NCD
器械分類3 類
醫療專科U
諮詢委員會MI

器材摘要

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.

常見問題

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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