QUANTIFERON - TB GOLD-IN-TUBE
FDA premarket approval P010033/S013 · decided 2008-10-31
Approval details
- PMA number
- P010033
- Supplement
- S013
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- QUANTIFERON - TB GOLD-IN-TUBE
- Generic name
- TEST, IMMUNITY, CELL MEDIATED, MYCOBACTERIUM TUBERCULOSIS
- Applicant
- Qiagen
- Date received
- 2008-06-10
- Decision date
- 2008-10-31
- Days to decision
- 143 days
- Decision code
- APPR
- Product code
- NCD
- Advisory committee
- Microbiology
- Expedited review
- No
- Location
- Germantown, MD
- Statement
- APPROVAL FOR THE ADDITION OF QUANTIFERON BLOOD COLLECTION TUBES SUITABLE FOR USE AT ALTITUDES ABOVE 6,500 FEET.
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510(k) clearances by this applicant
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