PMA P010033S048

Device: QUANTIFERON®-TB Gold Plus Test
Applicant: Qiagen
PMA number: P010033
Supplement: S048
Product code: NCD
Decision date: 2023-01-24
Generic name: TEST, IMMUNITY, CELL MEDIATED, MYCOBACTERIUM TUBERCULOSIS
Approval order statement: Approval of the addition of Sodium Heparin tubes as an alternative for blood collection in the workflow of the Quantiferon TB Gold Plus Test

Current openFDA PMA Record#

Device: QUANTIFERON®-TB Gold Plus Test
Applicant: Qiagen
PMA number: P010033
Supplement: S048
Product code: NCD
Generic name: TEST, IMMUNITY, CELL MEDIATED, MYCOBACTERIUM TUBERCULOSIS
Decision date: 2023-01-24
Decision code: APPR
Date received: 2022-09-30
Supplement type: Real-Time Process
Supplement reason: Labeling Change - Indications/instructions/shelf life/tradename
Approval order statement: Approval of the addition of Sodium Heparin tubes as an alternative for blood collection in the workflow of the Quantiferon TB Gold Plus Test