PMA P010033S015

Device: QUANTIFERON - TB GOLD IN-TUBE
Applicant: Qiagen
PMA number: P010033
Supplement: S015
Product code: NCD
Decision date: 2010-01-25
Classification: Test, Immunity, Cell Mediated, Mycobacterium Tuberculosis
Generic name: TEST, IMMUNITY, CELL MEDIATED, MYCOBACTERIUM TUBERCULOSIS
Approval order 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.

Current openFDA PMA Record#

Device: QUANTIFERON - TB GOLD IN-TUBE
Applicant: Qiagen
PMA number: P010033
Supplement: S015
Product code: NCD
Generic name: TEST, IMMUNITY, CELL MEDIATED, MYCOBACTERIUM TUBERCULOSIS
Decision date: 2010-01-25
Decision code: APPR
Date received: 2009-06-10
Supplement type: 135 Review Track For 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order 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.