Quanttferon-Tb Gold and TB Gold-In-The-Tube

FDA premarket approval P010033 · Test, Immunity, Cell Mediated, Mycobacterium Tuberculosis

PMA numberP010033

Approval

Applicant
Qiagen
Received
June 1, 2001
Decision date
November 28, 2001 (APPR)
Supplements
48, latest January 23, 2026
Product code
NCD – Test, Immunity, Cell Mediated, Mycobacterium Tuberculosis

Official FDA PMA record

Approval order statement

APPROVAL FOR THE CELLESTIS QUANTIFERON-TB. THE DEVICE IS INDICATED FOR USE AS AN AID IN THE DETECTION OF INFECTION WITH MYCOBACTERIUM TUBERCULOSIS.