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FDA PMA

Mycobacterium tuberculosis, Cell mediated immune response, enzyme-linked immunospot test

PMA Number: P070006 · 2025-08-04

ApplicantOxford Immunotec, Ltd.
Decision Date2025-08-04
PMA NumberP070006
Product CodeOJN
Device ClassClass 3
Medical SpecialtyU
Advisory CommitteeMI

Device Summary

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.

Frequently Asked Questions

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.

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.

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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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