T-SPOT TB TEST
FDA premarket approval P070006/S003 · decided 2010-03-04
Approval details
- PMA number
- P070006
- Supplement
- S003
- 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
- 2009-10-01
- Decision date
- 2010-03-04
- Days to decision
- 154 days
- Decision code
- APPR
- Product code
- OJN
- Advisory committee
- Microbiology
- Expedited review
- No
- Location
- Milton Park, Abingdon Oxfordshire
- Statement
- APPROVAL FOR THE INSTITUTION OF THE USE OF SEMI-AUTOMATED SYSTEM FOR THE DISPENSING AND CAPPING STAGES IN THE PRODUCTION OF THE POSITIVE CONTROL, PANEL A REAGENT, AND PANEL B REAGENT OF THE T-SPOT.TB TEST KIT USING THE FF30 DISPENSER/CAPPER FROM FLEXICON. IN ADDITION, THE TYPE OF VIAL CAPS HAS BEEN CHANGED FROM A POPCAN CAP TO A HDPE CAP WHICH IS NOW GAMMA IRRADIATED RATHER THAN AUTOCLAVED TO REDUCE BACTERIAL AND FUNGAL CONTAMINATION.
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