PMA P010033S017

Device: QUANTIFERON-TB GOLD IN-TUBE
Applicant: Qiagen
PMA number: P010033
Supplement: S017
Product code: NCD
Decision date: 2011-05-26
Classification: Test, Immunity, Cell Mediated, Mycobacterium Tuberculosis
Generic name: TEST, IMMUNITY, CELL MEDIATED, MYCOBACTERIUM TUBERCULOSIS
Approval order statement: APPROVAL FOR REVISIONS TO THE DEVICE PACKAGE INSERT AND MARKETING BOOKLET SUBSEQUENT TO THE PUBLICATION OFTHE CDC'S UPDATED GUIDELINES FOR USING INTERFERON GAMMA RELEASE ASSAYS TO DETECT MYCOBACTERIUM TUBERCULOSIS INFECTION - UNITED STATES, 2010, IN ACCORDANCE WITH THE ORIGINAL PMA POST-APPROVAL REQUIREMENT.

Current openFDA PMA Record#

Device: QUANTIFERON-TB GOLD IN-TUBE
Applicant: Qiagen
PMA number: P010033
Supplement: S017
Product code: NCD
Generic name: TEST, IMMUNITY, CELL MEDIATED, MYCOBACTERIUM TUBERCULOSIS
Decision date: 2011-05-26
Decision code: APPR
Date received: 2010-08-30
Supplement type: Special (Immediate Track)
Supplement reason: Labeling Change - Indications/instructions/shelf life/tradename
Approval order statement: APPROVAL FOR REVISIONS TO THE DEVICE PACKAGE INSERT AND MARKETING BOOKLET SUBSEQUENT TO THE PUBLICATION OFTHE CDC'S UPDATED GUIDELINES FOR USING INTERFERON GAMMA RELEASE ASSAYS TO DETECT MYCOBACTERIUM TUBERCULOSIS INFECTION - UNITED STATES, 2010, IN ACCORDANCE WITH THE ORIGINAL PMA POST-APPROVAL REQUIREMENT.