T-SPOT .TB TEST
FDA premarket approval P070006/S008 · decided 2012-09-05
Approval details
- PMA number
- P070006
- Supplement
- S008
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- T-SPOT .TB TEST
- Generic name
- Mycobacterium tuberculosis, Cell mediated immune response, enzyme-linked immunospot test
- Applicant
- Oxford Immunotec, Ltd.
- Date received
- 2012-08-27
- Decision date
- 2012-09-05
- Days to decision
- 9 days
- Decision code
- APPR
- Product code
- OJN
- Advisory committee
- Microbiology
- Expedited review
- No
- Location
- Milton Park, Abingdon Oxfordshire
- 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.
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