PMA P070006S007

Device: T-SPOT TB TEST
Applicant: Oxford Immunotec, Ltd.
PMA number: P070006
Supplement: S007
Product code: OJN
Decision date: 2011-11-23
Generic name: Mycobacterium tuberculosis, Cell mediated immune response, enzyme-linked immunospot test
Approval order statement: APPROVAL FOR THE ADDITION OF A NEW TEST KIT FORMAT WITH INCREASED REAGENT VOLUMES AND 50 ANTIBODY COATED 96-WELL MICROTITRE PLATES TO INCREASE THE KIT CAPACITY TO A TOTAL OF 1200 TESTS.

Current openFDA PMA Record#

Device: T-SPOT TB TEST
Applicant: Oxford Immunotec, Ltd.
PMA number: P070006
Supplement: S007
Product code: OJN
Generic name: Mycobacterium tuberculosis, Cell mediated immune response, enzyme-linked immunospot test
Decision date: 2011-11-23
Decision code: APPR
Date received: 2011-11-17
Supplement type: Real-Time Process
Supplement reason: Change Design/Components/Specifications/Material
Approval order statement: APPROVAL FOR THE ADDITION OF A NEW TEST KIT FORMAT WITH INCREASED REAGENT VOLUMES AND 50 ANTIBODY COATED 96-WELL MICROTITRE PLATES TO INCREASE THE KIT CAPACITY TO A TOTAL OF 1200 TESTS.