PMA P010033S023
- Device
- QUANTIFERON -TB GOLD
- Applicant
- Qiagen
- PMA number
- P010033
- Supplement
- S023
- Product code
- NCD
- Decision date
- 2014-01-31
- Classification
- Test, Immunity, Cell Mediated, Mycobacterium Tuberculosis
- Generic name
- TEST, IMMUNITY, CELL MEDIATED, MYCOBACTERIUM TUBERCULOSIS
- Approval order statement
- CHANGES TO INCORPORATE NEW BRANDING IN THE LABELING, TIGHTEN AN IN-PROCESS QC SPECIFICATION FOR THE BLOOD COLLECTION TUBES, AND ADD STEPS TO A RAW MATERIAL ACCEPTANCE PROCEDURE.
Current openFDA PMA Record#
- Device
- QUANTIFERON -TB GOLD
- Applicant
- Qiagen
- PMA number
- P010033
- Supplement
- S023
- Product code
- NCD
- Generic name
- TEST, IMMUNITY, CELL MEDIATED, MYCOBACTERIUM TUBERCULOSIS
- Decision date
- 2014-01-31
- Decision code
- OK30
- Date received
- 2013-12-23
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- CHANGES TO INCORPORATE NEW BRANDING IN THE LABELING, TIGHTEN AN IN-PROCESS QC SPECIFICATION FOR THE BLOOD COLLECTION TUBES, AND ADD STEPS TO A RAW MATERIAL ACCEPTANCE PROCEDURE.