PMA P070006S011
- Device
- T-SPOT .TB TEST
- Applicant
- Oxford Immunotec, Ltd.
- PMA number
- P070006
- Supplement
- S011
- Product code
- OJN
- Decision date
- 2013-09-03
- 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
- APPROVAL FOR A CHANGE TO REDUCE THE VOLUME OF COATING ANTIBODY FOR THE MICROCOAT GMBH (MICROCOAT) PLATES INCLUDED IN THE T-SPOT®.TB TEST KITS.
Current openFDA PMA Record#
- Device
- T-SPOT .TB TEST
- Applicant
- Oxford Immunotec, Ltd.
- PMA number
- P070006
- Supplement
- S011
- Product code
- OJN
- Generic name
- Mycobacterium tuberculosis, Cell mediated immune response, enzyme-linked immunospot test
- Decision date
- 2013-09-03
- Decision code
- APPR
- Date received
- 2013-02-19
- Supplement type
- 135 Review Track For 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- APPROVAL FOR A CHANGE TO REDUCE THE VOLUME OF COATING ANTIBODY FOR THE MICROCOAT GMBH (MICROCOAT) PLATES INCLUDED IN THE T-SPOT®.TB TEST KITS.