PMA P070006S016
- Device
- T-SPOT.TB TEST
- Applicant
- Oxford Immunotec, Ltd.
- PMA number
- P070006
- Supplement
- S016
- Product code
- OJN
- Decision date
- 2021-03-22
- Generic name
- Mycobacterium tuberculosis, Cell mediated immune response, enzyme-linked immunospot test
- Approval order statement
- Scale up of batch size for device components.
Current openFDA PMA Record#
- Device
- T-SPOT.TB TEST
- Applicant
- Oxford Immunotec, Ltd.
- PMA number
- P070006
- Supplement
- S016
- Product code
- OJN
- Generic name
- Mycobacterium tuberculosis, Cell mediated immune response, enzyme-linked immunospot test
- Decision date
- 2021-03-22
- Decision code
- OK30
- Date received
- 2021-03-09
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Scale up of batch size for device components.