QUANTIFERON - TB GOLD AND TB GOLD IN-TUBE
FDA premarket approval P010033/S014 · decided 2010-01-29
Approval details
- PMA number
- P010033
- Supplement
- S014
- Supplement type
- 135 Review Track For 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- QUANTIFERON - TB GOLD AND TB GOLD IN-TUBE
- Generic name
- TEST, IMMUNITY, CELL MEDIATED, MYCOBACTERIUM TUBERCULOSIS
- Applicant
- Qiagen
- Date received
- 2009-06-02
- Decision date
- 2010-01-29
- Days to decision
- 241 days
- Decision code
- APPR
- Product code
- NCD
- Advisory committee
- Microbiology
- Expedited review
- No
- Location
- Germantown, MD
- Statement
- APPROVAL FOR THE USE OF THE DRY ROOM AT SCANTIBODIES LABORATORY, INC., SANTEE, CALIFORNIA, TO BE USED AS AN ALTERNATIVE METHOD TO VACUUM DRYING IN THE MANUFACTURING PROCESS OF ELISA PLATES.
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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 |