PMA P070006S006

Device: T-SPOT .TB TEST
Applicant: Oxford Immunotec, Ltd.
PMA number: P070006
Supplement: S006
Product code: OJN
Decision date: 2012-01-04
Generic name: Mycobacterium tuberculosis, Cell mediated immune response, enzyme-linked immunospot test
Approval order statement: APPROVAL FOR THE USE OF T-CELL XTEND REAGENT IN EXTENDING WHOLE BLOOD STORAGE FROM 0-32 HOURS PRIOR TO ASSAYING WITH THE T-SPOT.TB TEST.

Current openFDA PMA Record#

Device: T-SPOT .TB TEST
Applicant: Oxford Immunotec, Ltd.
PMA number: P070006
Supplement: S006
Product code: OJN
Generic name: Mycobacterium tuberculosis, Cell mediated immune response, enzyme-linked immunospot test
Decision date: 2012-01-04
Decision code: APPR
Date received: 2011-07-12
Supplement type: Normal 180 Day Track
Supplement reason: Labeling Change - Indications/instructions/shelf life/tradename
Approval order statement: APPROVAL FOR THE USE OF T-CELL XTEND REAGENT IN EXTENDING WHOLE BLOOD STORAGE FROM 0-32 HOURS PRIOR TO ASSAYING WITH THE T-SPOT.TB TEST.