PMA P010033S029
- Device
- QUANTIFERON-TB GOLD AND TB GOLD Test (reference lab pack)
- Applicant
- Qiagen
- PMA number
- P010033
- Supplement
- S029
- Product code
- NCD
- Decision date
- 2016-08-19
- Classification
- Test, Immunity, Cell Mediated, Mycobacterium Tuberculosis
- Generic name
- TEST, IMMUNITY, CELL MEDIATED, MYCOBACTERIUM TUBERCULOSIS
- Approval order statement
- Addition of two alternate suppliers for a raw material used to produce a critical assay component.
Current openFDA PMA Record#
- Device
- QUANTIFERON-TB GOLD AND TB GOLD Test (reference lab pack)
- Applicant
- Qiagen
- PMA number
- P010033
- Supplement
- S029
- Product code
- NCD
- Generic name
- TEST, IMMUNITY, CELL MEDIATED, MYCOBACTERIUM TUBERCULOSIS
- Decision date
- 2016-08-19
- Decision code
- OK30
- Date received
- 2016-07-21
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Addition of two alternate suppliers for a raw material used to produce a critical assay component.