Clia Complexity |
Moderately Complex, CLIA Waiver Pending |
Detectable Analytes |
hCG in whole blood, plasma, or serum |
For Use With (Application) |
For in vitro diagnostic use only |
Format |
Lateral Flow |
Formulation |
The device contains material of human or animal origin |
Includes |
Product insert |
Measuring Range |
Clinical relevant cutoff: 10 mIU/mL |
Packaging |
Packaged in individually sealed pouches |
Sample Type |
Capillary or Venous blood/whole blood/plasma/serum |
Sensitivity |
10 mIU/mL |
Shelf Life |
15 Months |
Storage Requirements |
Stable unopened at 4°C-30°C (39°F-86°F Show more |
Test Time |
10 minutes |
Type |
Rapid diagnostic lateral flow assay |