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FDA PMA

TEST, IMMUNITY, CELL MEDIATED, MYCOBACTERIUM TUBERCULOSIS

PMA Number: P010033 · 2026-01-23

ApplicantQiagen
Decision Date2026-01-23
PMA NumberP010033
Product CodeNCD
Device ClassClass 3
Medical SpecialtyU
Advisory CommitteeMI

Device Summary

TEST, IMMUNITY, CELL MEDIATED, MYCOBACTERIUM TUBERCULOSIS is the device name listed in this FDA 510(k) record. The listed applicant is Qiagen. It received FDA 510(k) clearance on 2026-01-23. The device is classified under product code NCD. It was reviewed by the MI advisory panel.

Frequently Asked Questions

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 2026-01-23. The listed applicant is Qiagen.

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 Qiagen 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.

Related Clinical Trials

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITINGNCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITINGNCT04745156A Study Using Brain Stimulation and Behavioral Therapy to Increase Extent of Resection in Low-Grade GliomasNOT_YET_RECRUITINGNCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDED

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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