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QuantiFeron TB Gold and QuantiFeron TB Gold Plus

FDA PMA

Class III (US FDA PMA)

PMA P010033

by Qiagen

Identity

Trade Name
QUANTTFERON-TB GOLD AND TB GOLD-IN-THE-TUBE FDA PMA
Generic Name
TEST, IMMUNITY, CELL MEDIATED, MYCOBACTERIUM TUBERCULOSIS FDA PMA

Identifiers

PMA Number
P010033 FDA PMA
FDA Product Code
NCD FDA PMA

Classification

Device Class
Class III FDA PMA
Advisory Committee
Microbiology FDA PMA
FDA Decision
APPR Approved FDA PMA

The QuantiFeron TB Gold and QuantiFeron TB Gold Plus are in-vitro diagnostic devices classified as Test, Immunity, Cell Mediated, Mycobacterium Tuberculosis, designed to detect cell-mediated immunity to Mycobacterium tuberculosis. They measure interferon-gamma release in response to specific antigens, aiding in the differentiation between latent and active tuberculosis infection.

These devices are supplied as single-use kits for laboratory use, requiring no sterilisation beyond manufacturer-provided packaging. They are intended for use in clinical microbiology settings and are authorised under FDA_PMA (PMA Number: P010033). The QuantiFeron TB Gold Plus variant includes an additional antigen for enhanced specificity, while both versions comply with Device Class III regulatory standards.

This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: QuantiFERON-TB Gold Plus (QFT-Plus) Kits - Webshop - QIAGEN, How to test with QuantiFERON TB | QFT-Plus | QIAGEN, Qiagen N.V. - QIAGEN Highlights Newly Published Data Supporting ..., QIAGEN - QuantiFERON-TB Gold Plus

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_PMA

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Manufacturer

Manufacturer
Qiagen

Sources (1)

  • FDA PMA P010033 24 fields · synced Oct 6, 2026