T-SPOT TB TEST
FDA premarket approval P070006/S005 · decided 2011-05-04
Approval details
- PMA number
- P070006
- Supplement
- S005
- 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
- 2011-04-06
- Decision date
- 2011-05-04
- Days to decision
- 28 days
- Decision code
- OK30
- Product code
- OJN
- Advisory committee
- Microbiology
- Expedited review
- No
- Location
- Milton Park, Abingdon Oxfordshire
- Statement
- ADDITION OF A SECOND APPROVED SUPPLIER OF ANTIBODY COATED PLATES FOR THE DEVICE.
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