PMA P010033S035
- Device
- QuantiFERON - TB Gold Test and TB Gold Plus Test
- Applicant
- Qiagen
- PMA number
- P010033
- Supplement
- S035
- Product code
- NCD
- Decision date
- 2017-11-21
- Classification
- Test, Immunity, Cell Mediated, Mycobacterium Tuberculosis
- Generic name
- TEST, IMMUNITY, CELL MEDIATED, MYCOBACTERIUM TUBERCULOSIS
- Approval order statement
- Remove in-process QC testing of a raw material used to manufacture a kit subcomponent.
Current openFDA PMA Record#
- Device
- QuantiFERON - TB Gold Test and TB Gold Plus Test
- Applicant
- Qiagen
- PMA number
- P010033
- Supplement
- S035
- Product code
- NCD
- Generic name
- TEST, IMMUNITY, CELL MEDIATED, MYCOBACTERIUM TUBERCULOSIS
- Decision date
- 2017-11-21
- Decision code
- OK30
- Date received
- 2017-10-31
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Remove in-process QC testing of a raw material used to manufacture a kit subcomponent.