T-SPOT TB TEST
FDA premarket approval P070006/S001 · decided 2010-07-09
Approval details
- PMA number
- P070006
- Supplement
- S001
- Supplement type
- Normal 180 Day Track
- 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
- 2009-02-27
- Decision date
- 2010-07-09
- Days to decision
- 497 days
- Decision code
- APPR
- Product code
- OJN
- Advisory committee
- Microbiology
- Expedited review
- No
- Location
- Milton Park, Abingdon Oxfordshire
- Statement
- APPROVAL FOR THE USE OF T-CELL XTEND REAGENT WITH THE T-SPOT.TB TEST, IN ORDER TO EXTEND THE TIME FROM SAMPLE COLLECTION TO SAMPLE PROCESSING FROM WITHIN 8 HOURS OF VENIPUNCTURE TO BETWEEN 23 AND 30 HOURS POST VENIPUNCTURE; AND TO MAKE A TECHNICAL CORRECTION TO THE T-SPOT.TB TEST PACKAGE INSERT TO CHANGE THE NUMBER OF BLOOD COLLECTION TUBES REQUIRED FROM (2) 6 ML HEPARIN TUBES TO (1) 6 ML HEPARIN TUBE. THE T-CELL XTEND REAGENT IS INDICATED FOR USE WITH THE T-SPOT.TB TEST FOR THE PRE-TREATMENT OF
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