QUANTIFERON-TB GOLD
FDA premarket approval P010033/S010 · decided 2006-03-10
Approval details
- PMA number
- P010033
- Supplement
- S010
- Supplement type
- Special (Immediate Track)
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Trade name
- QUANTIFERON-TB GOLD
- Generic name
- TEST, IMMUNITY, CELL MEDIATED, MYCOBACTERIUM TUBERCULOSIS
- Applicant
- Qiagen
- Date received
- 2006-02-14
- Decision date
- 2006-03-10
- Days to decision
- 24 days
- Decision code
- APPR
- Product code
- NCD
- Advisory committee
- Microbiology
- Expedited review
- No
- Location
- Germantown, MD
- Statement
- APPROVAL FOR LABLEING CHANGE TO THE WORDING OF THE INTERPRETATION OF THE TEST TO REMOVE AMBIGUITY AND ENHANCE SAFE USE.
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510(k) clearances by this applicant
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|---|---|---|
| artus HSV-1/2 QS-RGQ MDx Kit (K142738) | Qiagen | 2014-12-19 |