PMA P010033S003

Device: QUANTIFERON-TB
Applicant: Qiagen
PMA number: P010033
Supplement: S003
Product code: NCD
Decision date: 2003-03-17
Classification: Test, Immunity, Cell Mediated, Mycobacterium Tuberculosis
Generic name: TEST, IMMUNITY, CELL MEDIATED, MYCOBACTERIUM TUBERCULOSIS
Approval order statement: APPROVAL FOR LABELING CHANGES TO THE INSTRUCTIONS FOR USE THAT ENHANCE THE SAFE USE OF THE QUANTIFERON-TB BY INCORPORATING RECOMMENDATIONS FROM THE "CDC GUIDELINES FOR USING THE QUANTIFERON-TB TEST FOR DIAGNOSING LATENT MYCOBACTERIUM TUBERCULOSIS INFECTION" (MMWR DISPATCH, VOL. 51/DECEMBER 18, 2002).

Current openFDA PMA Record#

Device: QUANTIFERON-TB
Applicant: Qiagen
PMA number: P010033
Supplement: S003
Product code: NCD
Generic name: TEST, IMMUNITY, CELL MEDIATED, MYCOBACTERIUM TUBERCULOSIS
Decision date: 2003-03-17
Decision code: APPR
Date received: 2003-02-20
Supplement type: Special (Immediate Track)
Supplement reason: Labeling Change - Indications/instructions/shelf life/tradename
Approval order statement: APPROVAL FOR LABELING CHANGES TO THE INSTRUCTIONS FOR USE THAT ENHANCE THE SAFE USE OF THE QUANTIFERON-TB BY INCORPORATING RECOMMENDATIONS FROM THE "CDC GUIDELINES FOR USING THE QUANTIFERON-TB TEST FOR DIAGNOSING LATENT MYCOBACTERIUM TUBERCULOSIS INFECTION" (MMWR DISPATCH, VOL. 51/DECEMBER 18, 2002).