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Technical Specifications
[ 01 ]
Device Calibration
Calibration intervals of 12 months or per manufacturer guidelines. Traceable to NIST standards for precision and accuracy in diagnostic testing environments.
[ 02 ]
Reagent Stability
Stability testing conducted at 25°C and 37°C. Shelf life of 24 months from the date of manufacture, verified through rigorous accelerated aging protocols.
[ 03 ]
Compliance
Full compliance with ISO 13485:2016 and FDA 21 CFR Part 820. Documentation available for clinical audits and regulatory submissions.
[ 04 ]
Material Safety
Materials tested for biocompatibility under ISO 10993-1. Non-toxic and inert surfaces designed for direct contact with blood samples.
[ 05 ]
Temperature Range
Operating temperature range: 15°C to 40°C. Designed for reliable performance across a wide spectrum of clinical laboratory environments.
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