QUANTIFERON - TB GOLD IN-TUBE
FDA premarket approval P010033/S015 · decided 2010-01-25
Approval details
- PMA number
- P010033
- Supplement
- S015
- Supplement type
- 135 Review Track For 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- QUANTIFERON - TB GOLD IN-TUBE
- Generic name
- TEST, IMMUNITY, CELL MEDIATED, MYCOBACTERIUM TUBERCULOSIS
- Applicant
- Qiagen
- Date received
- 2009-06-10
- Decision date
- 2010-01-25
- Days to decision
- 229 days
- Decision code
- APPR
- Product code
- NCD
- Advisory committee
- Microbiology
- Expedited review
- No
- Location
- Germantown, MD
- Statement
- APPROVAL TO ALLOW THE USE OF DRY PEPTIDES TO BE FORMULATED AT CELLESTIS AND SHIPPED TO THE CONTRACT MANUFACTURER FOR THE MANUFACTURE OF TB ANTIGEN BLOOD COLLECTION TUBES.
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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 |