Transcription of Package Insert - T-SPOT.com
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Package Insert - T-SPOT.com
PI-TB-US-V5 Package Insert For In Vitro Diagnostic Use Only This Package Insert covers use of: 8 (Multi-use 8-Well Strip Plate Format. Catalogue number: ) 50 (1200 test 96-Well Plate Format. Catalogue number: ) Caution: Federal (USA) law restricts this device to sale by or on the order of a licensed health care professional Package Insert PI-TB-US-V5 Page 2 of 36 INDEX 1. INTENDED USE .. 3 2. SUMMARY & EXPLANATION .. 3 Principle of Test .. 4 3. REAGENTS & storage .. 5 Materials Provided .. 5 storage & Stability .. 5 Equipment and Materials Required but Not Provided .. 6 4. WARNINGS & PRECAUTIONS .. 6 5. SPECIMEN COLLECTION & HANDLING .. 7 6. INSTRUCTIONS FOR USE .. 8 Reagent Preparation .. 9 Cell Counting and Dilution .. 9 Plate Set Up and Incubation .. 10 Spot Development and Counting .. 11 Quality Control .. 12 Results Interpretation and Assay Criteria .. 12 7. LIMITATIONS .. 15 8. EXPECTED VALUES .. 16 9. PERFORMANCE CHARACTERISTICS.
T-SPOT.TB Package Insert PI-TB-US-V5 Page 5 of 36 3. REAGENTS & STORAGE MATERIALS PROVIDED T-SPOT.TB 8 (Multi-use 12 x 8-well strip version) contains: 1. 1 microtiter plate: 96 wells, supplied as 12x 8-well strips in a …
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