PMA P070006S019
- Device
- T-SPOT ®.TB
- Applicant
- Oxford Immunotec, Ltd.
- PMA number
- P070006
- Supplement
- S019
- Product code
- OJN
- Decision date
- 2023-03-27
- Classification
- Microbiology
- Generic name
- Mycobacterium tuberculosis, Cell mediated immune response, enzyme-linked immunospot test
- Approval order statement
- Changes to the incoming QC method for one of the components in a Reagent kit.
Current openFDA PMA Record#
- Device
- T-SPOT ®.TB
- Applicant
- Oxford Immunotec, Ltd.
- PMA number
- P070006
- Supplement
- S019
- Product code
- OJN
- Generic name
- Mycobacterium tuberculosis, Cell mediated immune response, enzyme-linked immunospot test
- Decision date
- 2023-03-27
- Decision code
- OK30
- Date received
- 2023-03-06
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Changes to the incoming QC method for one of the components in a Reagent kit.