PMA P070006S005
- Device
- T-SPOT TB TEST
- Applicant
- Oxford Immunotec, Ltd.
- PMA number
- P070006
- Supplement
- S005
- Product code
- OJN
- Decision date
- 2011-05-04
- Classification
- Mycobacterium Tuberculosis, Cell Mediated Immune Response, Enzyme-linked Immunospot Test
- Generic name
- Mycobacterium tuberculosis, Cell mediated immune response, enzyme-linked immunospot test
- Approval order statement
- ADDITION OF A SECOND APPROVED SUPPLIER OF ANTIBODY COATED PLATES FOR THE DEVICE.
Current openFDA PMA Record#
- Device
- T-SPOT TB TEST
- Applicant
- Oxford Immunotec, Ltd.
- PMA number
- P070006
- Supplement
- S005
- Product code
- OJN
- Generic name
- Mycobacterium tuberculosis, Cell mediated immune response, enzyme-linked immunospot test
- Decision date
- 2011-05-04
- Decision code
- OK30
- Date received
- 2011-04-06
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- ADDITION OF A SECOND APPROVED SUPPLIER OF ANTIBODY COATED PLATES FOR THE DEVICE.