Quantiferon - TB Gold Plus Test
FDA premarket approval P010033/S045 · decided 2019-04-29
Approval details
- PMA number
- P010033
- Supplement
- S045
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- Quantiferon - TB Gold Plus Test
- Generic name
- TEST, IMMUNITY, CELL MEDIATED, MYCOBACTERIUM TUBERCULOSIS
- Applicant
- Qiagen
- Date received
- 2019-04-15
- Decision date
- 2019-04-29
- Days to decision
- 14 days
- Decision code
- APPR
- Product code
- NCD
- Advisory committee
- Microbiology
- Expedited review
- No
- Location
- Germantown, MD
- Statement
- Approval for changes to the stability/handling of whole blood specimens collected in lithium heparin (LiHep) blood collection tubes held at 2-8C, prior to transfer to the Quantiferon-TB Gold Plus 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 |