PMA P070006
- Device
- T-SPOT.TB Test
- Applicant
- Oxford Immunotec, Ltd.
- PMA number
- P070006
- Supplement
- S017
- Product code
- OJN
- Decision date
- 2025-08-04
- Generic name
- Mycobacterium tuberculosis, Cell mediated immune response, enzyme-linked immunospot test
- Approval order statement
- a supplier increase in manufacturing scale
Current openFDA PMA Record#
- Device
- T-SPOT.TB Test
- Applicant
- Oxford Immunotec, Ltd.
- PMA number
- P070006
- Supplement
- S028
- Product code
- OJN
- Generic name
- Mycobacterium tuberculosis, Cell mediated immune response, enzyme-linked immunospot test
- Decision date
- 2025-08-04
- Decision code
- OK30
- Date received
- 2025-07-07
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- a supplier increase in manufacturing scale