FDA.reportPublic FDA data

PMA P010033S019

Device
QUANTIFERON -TB GOLD
Applicant
Qiagen
PMA number
P010033
Supplement
S019
Product code
NCD
Decision date
2011-10-20
Classification
Test, Immunity, Cell Mediated, Mycobacterium Tuberculosis
Generic name
TEST, IMMUNITY, CELL MEDIATED, MYCOBACTERIUM TUBERCULOSIS
Approval order statement
APPROVAL FOR CHANGES TO THE LABELING: INSTRUCTIONS FOR USE SECTION, SPECIMEN COLLECTION AND HANDLING SECTION, AND ABBREVIATED TEST PROCEDURE SECTION FOR USE OF THE QUANTIFERON® BLOOD COLLECTION TUBES.

Current openFDA PMA Record#

Device
QUANTIFERON -TB GOLD
Applicant
Qiagen
PMA number
P010033
Supplement
S019
Product code
NCD
Generic name
TEST, IMMUNITY, CELL MEDIATED, MYCOBACTERIUM TUBERCULOSIS
Decision date
2011-10-20
Decision code
APPR
Date received
2011-08-04
Supplement type
Special (Immediate Track)
Supplement reason
Labeling Change - Indications/instructions/shelf life/tradename
Approval order statement
APPROVAL FOR CHANGES TO THE LABELING: INSTRUCTIONS FOR USE SECTION, SPECIMEN COLLECTION AND HANDLING SECTION, AND ABBREVIATED TEST PROCEDURE SECTION FOR USE OF THE QUANTIFERON® BLOOD COLLECTION TUBES.