PMA P010033S004
- Device
- QUANTIFERON-TB ANALYSIS SOFTWARE PROGRAM
- Applicant
- Qiagen
- PMA number
- P010033
- Supplement
- S004
- Product code
- NCD
- Decision date
- 2003-08-07
- Classification
- Test, Immunity, Cell Mediated, Mycobacterium Tuberculosis
- Generic name
- TEST, IMMUNITY, CELL MEDIATED, MYCOBACTERIUM TUBERCULOSIS
- Approval order statement
- APPROVAL FOR THE USE OF THE QUANTIFERON-TB ANALYSIS SOFTWARE PROGRAM FOR USE WITH THE QUANTIFERON-TB TEST. THE DEVICE ACCESSORY WILL BE MARKETED UNDER THE TRADE NAME QUANTIFERON-TB ANALYSIS SOFTWARE PROGRAM AND IS INDICATED AS A STAND ALONE PROGRAM FOR ANALYSIS OF RAW EIA DATA AND CALCULATION OF QUANTIFERON-TB ASSAY RESULTS.
Current openFDA PMA Record#
- Device
- QUANTIFERON-TB ANALYSIS SOFTWARE PROGRAM
- Applicant
- Qiagen
- PMA number
- P010033
- Supplement
- S004
- Product code
- NCD
- Generic name
- TEST, IMMUNITY, CELL MEDIATED, MYCOBACTERIUM TUBERCULOSIS
- Decision date
- 2003-08-07
- Decision code
- APPR
- Date received
- 2003-02-28
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- APPROVAL FOR THE USE OF THE QUANTIFERON-TB ANALYSIS SOFTWARE PROGRAM FOR USE WITH THE QUANTIFERON-TB TEST. THE DEVICE ACCESSORY WILL BE MARKETED UNDER THE TRADE NAME QUANTIFERON-TB ANALYSIS SOFTWARE PROGRAM AND IS INDICATED AS A STAND ALONE PROGRAM FOR ANALYSIS OF RAW EIA DATA AND CALCULATION OF QUANTIFERON-TB ASSAY RESULTS.