Microbiology Devices Panel Meeting
Thursday, October 12, 2001
Premarket Approval Application: Cellestis Limited, QuantiFERON-TB. An in vitro diagnostic device for measuring the release of gamma-interferon from sensitized lymphocytes in PPD-stimulated whole blood. Intended as an aid in the diagnosis of latent tuberculosis infection, and to aid in the evaluation of individuals suspected of having M. tuberculosis infection.
The statements contained in this document(s) are those of the product's sponsor, not FDA, and FDA does not necessarily agree with the sponsor's statements. FDA has not made a final determination about the safety or effectiveness of the product described in this document.
Draft Summary of Safety and Effectiveness - QuantiFERON -TB pdf