PMA P070006S008
- Device
- T-SPOT .TB TEST
- Applicant
- Oxford Immunotec, Ltd.
- PMA number
- P070006
- Supplement
- S008
- Product code
- OJN
- Decision date
- 2012-09-05
- 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 DESIGN CHANGE, FOR A LARGER REAGENT VOLUME FORMAT FORTHE T-CELL XTEND REAGENT, AN ACCESSORY TO THE T-SPOT TB TEST, TO INCREASE THE VOLUME FROM 3 X 2ML VIALS IN A PACK TO A 50ML BOTTLE.
Current openFDA PMA Record#
- Device
- T-SPOT .TB TEST
- Applicant
- Oxford Immunotec, Ltd.
- PMA number
- P070006
- Supplement
- S008
- Product code
- OJN
- Generic name
- Mycobacterium tuberculosis, Cell mediated immune response, enzyme-linked immunospot test
- Decision date
- 2012-09-05
- Decision code
- APPR
- Date received
- 2012-08-27
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- APPROVAL FOR A DESIGN CHANGE, FOR A LARGER REAGENT VOLUME FORMAT FORTHE T-CELL XTEND REAGENT, AN ACCESSORY TO THE T-SPOT TB TEST, TO INCREASE THE VOLUME FROM 3 X 2ML VIALS IN A PACK TO A 50ML BOTTLE.