PMA P010033S011
- Device
- QUANTIFERON TB GOLD IN TUBE
- Applicant
- Qiagen
- PMA number
- P010033
- Supplement
- S011
- Product code
- NCD
- Decision date
- 2007-10-10
- Classification
- Test, Immunity, Cell Mediated, Mycobacterium Tuberculosis
- Generic name
- TEST, IMMUNITY, CELL MEDIATED, MYCOBACTERIUM TUBERCULOSIS
- Approval order statement
- APPROVAL FOR A MODIFICATION OF THE QUANTIFERON - TB GOLD TO AN IN-TUBE COLLECTION SYSTEM THAT CONSISTS OF THREE BLOOD COLLECTION TUBES, NIL, TB ANTIGEN, AND MITOGEN. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME QUANTIFERON - TB GOLD IN-TUBE AND IS INDICATED FOR USE AS AN IN VITRO DIAGNOSTIC TEST USING A PEPTIDE COCKTAIL SIMULATING ESAT-6, CFP-10 AND TB 7.7(P4) PROTEINS TO STIMULATE CELLS IN HEPARINIZED WHOLE BLOOD DRAWN DIRECTLY INTO SPECIALIZED BLOOD COLLECTION TUBES. DETECTION OF INTERFERON-Y BY ENZYME-LINKED IMMUNOSORBENT ASSAY (ELISA) IS USED TO IDENTIFY IN VITRO RESPONSES TO THESE PEPTIDE ANTIGENS THAT ARE ASSOCIATED WITH MYCOBACTERIUM TUBERCULOSIS INFECTION.
Current openFDA PMA Record#
- Device
- QUANTIFERON TB GOLD IN TUBE
- Applicant
- Qiagen
- PMA number
- P010033
- Supplement
- S011
- Product code
- NCD
- Generic name
- TEST, IMMUNITY, CELL MEDIATED, MYCOBACTERIUM TUBERCULOSIS
- Decision date
- 2007-10-10
- Decision code
- APPR
- Date received
- 2006-06-01
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- APPROVAL FOR A MODIFICATION OF THE QUANTIFERON - TB GOLD TO AN IN-TUBE COLLECTION SYSTEM THAT CONSISTS OF THREE BLOOD COLLECTION TUBES, NIL, TB ANTIGEN, AND MITOGEN. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME QUANTIFERON - TB GOLD IN-TUBE AND IS INDICATED FOR USE AS AN IN VITRO DIAGNOSTIC TEST USING A PEPTIDE COCKTAIL SIMULATING ESAT-6, CFP-10 AND TB 7.7(P4) PROTEINS TO STIMULATE CELLS IN HEPARINIZED WHOLE BLOOD DRAWN DIRECTLY INTO SPECIALIZED BLOOD COLLECTION TUBES. DETECTION OF INTERFERON-Y BY ENZYME-LINKED IMMUNOSORBENT ASSAY (ELISA) IS USED TO IDENTIFY IN VITRO RESPONSES TO THESE PEPTIDE ANTIGENS THAT ARE ASSOCIATED WITH MYCOBACTERIUM TUBERCULOSIS INFECTION.