PMA P010033S006
- Device
- QUANTIFERON -TB GOLD
- Applicant
- Qiagen
- PMA number
- P010033
- Supplement
- S006
- Product code
- NCD
- Decision date
- 2004-12-02
- Classification
- Test, Immunity, Cell Mediated, Mycobacterium Tuberculosis
- Generic name
- TEST, IMMUNITY, CELL MEDIATED, MYCOBACTERIUM TUBERCULOSIS
- Approval order statement
- APPROVAL FOR THE USE OF SYNTHETIC PEPTIDE ANTIGENS ESAT-6 AND CFP-10 AND REMOVAL OF THE TUBERCULIN PPD AND M. AVIUM PPD ANTIGENS USED IN THE QUANTIFERON - TB. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME QUANTIFERON - TB GOLD AND IS INDICATED FOR USE AS AN IN VITRO DIAGNOSTIC TEST USING PEPTIDE COCKTAILS SIMULATING ESAT-6 AND CFP-10 PROTEINS TO STIMULATE CELLS IN HEPARINIZED WHOLE BLOOD. DETECTION OF INTERFERON-Y BY ELISA IS USED TO IDENTIFY IN VITRO RESPONSES TO ESAT-6 AND CFP-10 THAT ARE ASSOCIATED WITH MYCOBACTERIUM TUBERCULOSIS INFECTION. THE DEVICE APPROVAL IS FOR USE OF AN 8-POINT CALIBRATION CURVE WITH MANUAL CALCULATIONS.
Current openFDA PMA Record#
- Device
- QUANTIFERON -TB GOLD
- Applicant
- Qiagen
- PMA number
- P010033
- Supplement
- S006
- Product code
- NCD
- Generic name
- TEST, IMMUNITY, CELL MEDIATED, MYCOBACTERIUM TUBERCULOSIS
- Decision date
- 2004-12-02
- Decision code
- APPR
- Date received
- 2003-12-04
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- APPROVAL FOR THE USE OF SYNTHETIC PEPTIDE ANTIGENS ESAT-6 AND CFP-10 AND REMOVAL OF THE TUBERCULIN PPD AND M. AVIUM PPD ANTIGENS USED IN THE QUANTIFERON - TB. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME QUANTIFERON - TB GOLD AND IS INDICATED FOR USE AS AN IN VITRO DIAGNOSTIC TEST USING PEPTIDE COCKTAILS SIMULATING ESAT-6 AND CFP-10 PROTEINS TO STIMULATE CELLS IN HEPARINIZED WHOLE BLOOD. DETECTION OF INTERFERON-Y BY ELISA IS USED TO IDENTIFY IN VITRO RESPONSES TO ESAT-6 AND CFP-10 THAT ARE ASSOCIATED WITH MYCOBACTERIUM TUBERCULOSIS INFECTION. THE DEVICE APPROVAL IS FOR USE OF AN 8-POINT CALIBRATION CURVE WITH MANUAL CALCULATIONS.