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- Uses whole blood (capillary or venous), plasma, or serum
- >99% sensitivity and specificity
- Clinical relevant cutoff: 10 mIU/mL
- Small sample volume test (about 40 μL)
- Results in 10 minutes, no waiting on urine samples
- No reagents or buffers
- Reduced exposure to liability from false negatives
- Increased patient throughput
Certifications
FDA Approved in USA; CE Marked in Europe
Specifications
Content And Storage
Stable unopened at 4°C-30°C (39°F-86°F) until the expiration date.
CE Marker
Yes
Clia Complexity
Moderate (Waiver Pending)
Detectable Analytes
hCG
Sample Type
Capillary or Venous blood/whole blood/plasma/serum
Sensitivity
10 mIU/mL
Type
Rapid Diagnostic Lateral Flow Assay
Disposable
Single-use
Formulation
The device contains material of human or animal origin
For Use With (Application)
For in vitro diagnostic use only
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