PMA P010033S051

Device: QuantiFERON-TB Gold Plus Test
Applicant: Qiagen
PMA number: P010033
Supplement: S051
Product code: NCD
Decision date: 2025-11-21
Classification: Microbiology
Generic name: TEST, IMMUNITY, CELL MEDIATED, MYCOBACTERIUM TUBERCULOSIS
Approval order statement: Approval for a design change to the device TB Antigen blood collection tubes (QuantiFERON TB Gold Pro Blood Collection Tubes) with the QuantiFERON-TB Gold Plus Test

Current openFDA PMA Record#

Device: QuantiFERON-TB Gold Plus Test
Applicant: Qiagen
PMA number: P010033
Supplement: S051
Product code: NCD
Generic name: TEST, IMMUNITY, CELL MEDIATED, MYCOBACTERIUM TUBERCULOSIS
Decision date: 2025-11-21
Decision code: APPR
Date received: 2025-08-28
Supplement type: Real-Time Process
Supplement reason: Change Design/Components/Specifications/Material
Approval order statement: Approval for a design change to the device TB Antigen blood collection tubes (QuantiFERON TB Gold Pro Blood Collection Tubes) with the QuantiFERON-TB Gold Plus Test