QuantiFERON-TB Gold Test / QuantiFERON TB Gold Plus Test
FDA premarket approval P010033/S041 · decided 2018-10-30
Approval details
- PMA number
- P010033
- Supplement
- S041
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- QuantiFERON-TB Gold Test / QuantiFERON TB Gold Plus Test
- Generic name
- TEST, IMMUNITY, CELL MEDIATED, MYCOBACTERIUM TUBERCULOSIS
- Applicant
- Qiagen
- Date received
- 2018-09-25
- Decision date
- 2018-10-30
- Days to decision
- 35 days
- Decision code
- APPR
- Product code
- NCD
- Advisory committee
- Microbiology
- Expedited review
- No
- Location
- Germantown, MD
- Statement
- Approval for change in critical raw material of kit component.
Class III intelligence, same tools
PMAs share the API, exports and alerts with 510(k) data - watch an applicant and hear about every approval.
510(k) clearances by this applicant
| Record | Firm | Date |
|---|---|---|
| artus HSV-1/2 QS-RGQ MDx Kit (K142738) | Qiagen | 2014-12-19 |