PMA P010033S014

Device: QUANTIFERON - TB GOLD AND TB GOLD IN-TUBE
Applicant: Qiagen
PMA number: P010033
Supplement: S014
Product code: NCD
Decision date: 2010-01-29
Classification: Test, Immunity, Cell Mediated, Mycobacterium Tuberculosis
Generic name: TEST, IMMUNITY, CELL MEDIATED, MYCOBACTERIUM TUBERCULOSIS
Approval order 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.

Current openFDA PMA Record#

Device: QUANTIFERON - TB GOLD AND TB GOLD IN-TUBE
Applicant: Qiagen
PMA number: P010033
Supplement: S014
Product code: NCD
Generic name: TEST, IMMUNITY, CELL MEDIATED, MYCOBACTERIUM TUBERCULOSIS
Decision date: 2010-01-29
Decision code: APPR
Date received: 2009-06-02
Supplement type: 135 Review Track For 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order 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.