QUANTIFERON -TB GOLD
FDA premarket approval P010033/S020 · decided 2012-11-15
Approval details
- PMA number
- P010033
- Supplement
- S020
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- QUANTIFERON -TB GOLD
- Generic name
- TEST, IMMUNITY, CELL MEDIATED, MYCOBACTERIUM TUBERCULOSIS
- Applicant
- Qiagen
- Date received
- 2012-04-11
- Decision date
- 2012-11-15
- Days to decision
- 218 days
- Decision code
- APPR
- Product code
- NCD
- Advisory committee
- Microbiology
- Expedited review
- No
- Location
- Germantown, MD
- Statement
- APPROVAL FOR A CHANGE IN THE FORMULATION OF THE WASH BUFFER 20X CONCENTRATE.
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510(k) clearances by this applicant
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