QuantiFERON®-TB Gold, QuantiFERON®-TB Gold Plus
FDA premarket approval P010033/S047 · decided 2021-12-13
Approval details
- PMA number
- P010033
- Supplement
- S047
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Trade name
- QuantiFERON®-TB Gold, QuantiFERON®-TB Gold Plus
- Generic name
- TEST, IMMUNITY, CELL MEDIATED, MYCOBACTERIUM TUBERCULOSIS
- Applicant
- Qiagen
- Date received
- 2021-03-26
- Decision date
- 2021-12-13
- Days to decision
- 262 days
- Decision code
- APPR
- Product code
- NCD
- Advisory committee
- Microbiology
- Expedited review
- No
- Location
- Germantown, MD
- Statement
- Approval for the following changes to the QuantiFERON®-TB Gold, QuantiFERON®-TB Gold Plus device packge inserts:1) Removal of the following language from the Warnings and Precautions section from the QuantiFERON®-TB Gold device packge insert:The performance of the USA format of the QFT test has not been extensively evaluated with specimens from the following groups of individuals: I. Individuals who have impaired or altered immune functions, such as those who have HIV infection or AIDS, those wh
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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 |