- Device
- T-SPOT.TB Test
- Applicant
- Oxford Immunotec, Ltd.
- PMA number
- P070006
- Supplement
- S017
- Product code
- OJN
- Generic name
- Mycobacterium tuberculosis, Cell mediated immune response, enzyme-linked immunospot test
- Decision date
- 2021-07-26
- Decision code
- APPR
- Date received
- 2021-05-03
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Location Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Approval to include an additional manufacturing site establishment to perform manufacturing of the device.