T-SPOT .TB TEST
FDA premarket approval P070006/S009 · decided 2013-06-12
Approval details
- PMA number
- P070006
- Supplement
- S009
- Supplement type
- 135 Review Track For 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- T-SPOT .TB TEST
- Generic name
- Mycobacterium tuberculosis, Cell mediated immune response, enzyme-linked immunospot test
- Applicant
- Oxford Immunotec, Ltd.
- Date received
- 2012-09-04
- Decision date
- 2013-06-12
- Days to decision
- 281 days
- Decision code
- APPR
- Product code
- OJN
- Advisory committee
- Microbiology
- Expedited review
- No
- Location
- Milton Park, Abingdon Oxfordshire
- Statement
- APPROVAL FOR THE ADDITION OF A SECOND APPROVED SUPPLIER FOR THE CONJUGATED SECONDARY ANTIBODY
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