T-SPOT .TB TEST
FDA premarket approval P070006/S002 · decided 2009-10-22
Approval details
- PMA number
- P070006
- Supplement
- S002
- Supplement type
- 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
- 2009-09-30
- Decision date
- 2009-10-22
- Days to decision
- 22 days
- Decision code
- OK30
- Product code
- OJN
- Advisory committee
- Microbiology
- Expedited review
- No
- Location
- Milton Park, Abingdon Oxfordshire
- Statement
- ADDITION OF AN EXTRA APPROVED SUPPLIER OF PEPTIDES.
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