Description
- Format: Cassette with 4 mm test strip
- Sensitivity: Detects levels as low as 10–25 mIU/mL depending on configuration detection thresholds
- Accuracy: Claimed over 99% specificity / sensitivity in clinical evaluation
- Certifications: CE‑marked and ISO‑certified (ISO 9001, ISO 13485)
- Shelf-Life & Storage: Typically 24–36 months at room temperature (2–30 °C)
- Result Time: Provides results in approximately 3–5 minutes
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