PMA P070006S014

Device: T SPOT-TB Test
Applicant: Oxford Immunotec, Ltd.
PMA number: P070006
Supplement: S014
Product code: OJN
Decision date: 2020-08-11
Generic name: Mycobacterium tuberculosis, Cell mediated immune response, enzyme-linked immunospot test
Approval order statement: Approval for change to the age limitation in the current T-SPOT.TB test labeling to allow use of the test in individuals 2 years of age and older.

Current openFDA PMA Record#

Device: T SPOT-TB Test
Applicant: Oxford Immunotec, Ltd.
PMA number: P070006
Supplement: S014
Product code: OJN
Generic name: Mycobacterium tuberculosis, Cell mediated immune response, enzyme-linked immunospot test
Decision date: 2020-08-11
Decision code: APPR
Date received: 2020-03-30
Supplement type: Normal 180 Day Track
Supplement reason: Labeling Change - Indications/instructions/shelf life/tradename
Approval order statement: Approval for change to the age limitation in the current T-SPOT.TB test labeling to allow use of the test in individuals 2 years of age and older.