QUANTTFERON-TB GOLD Plus
FDA premarket approval P010033/S031 · decided 2017-06-07
Approval details
- PMA number
- P010033
- Supplement
- S031
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- QUANTTFERON-TB GOLD Plus
- Generic name
- TEST, IMMUNITY, CELL MEDIATED, MYCOBACTERIUM TUBERCULOSIS
- Applicant
- Qiagen
- Date received
- 2016-12-09
- Decision date
- 2017-06-07
- Days to decision
- 180 days
- Decision code
- APPR
- Product code
- NCD
- Advisory committee
- Microbiology
- Expedited review
- No
- Location
- Germantown, MD
- Statement
- Approval for a design change to the device TB Antigen blood collection tubes.
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510(k) clearances by this applicant
| Record | Firm | Date |
|---|---|---|
| artus HSV-1/2 QS-RGQ MDx Kit (K142738) | Qiagen | 2014-12-19 |