- Single reagent procedure provides positive results in 3–8 minutes.
- Fingerstick whole blood capability (CLIA waived) for easy screening.
- Walkaway procedure accommodates interruptions in workflow.
- Sensitivity 99.9% • Specificity 98.8%.
- Kit includes controls, developer solution, procedure card, and transfer pipettes.
- SKU:
- 552343
- QTY Per Sell:
- 30
- Number of Tests:
- 30 Tests
- Reading Type:
- Visual Read
- Sample Type:
- Whole Blood / Serum / Plasma Sample
- CLIA Classification:
- li>CLIA waived for whole blood
- Moderate complexity for serum/plasma
- Regulatory Status:
- FDA cleared with no age restrictions
- Time To Results:
- 3–8 minutes
- Sample Volume Required:
- 25 µL whole blood; 10 µL serum/plasma
- Test Method:
- Solid-phase chromatographic lateral flow immunoassay
- Kit Contents:
- 30 test devices
- Positive & negative controls
- Developer solution & pipettes
- Storage Temperature:
- Store at 36°–86° F (2–30° C)
- Manufacturer:
- LifeSign (Status™ brand)
- Country of Origin:
- United States
- Intended Use:
- Qualitative detection of heterophile antibodies for IM diagnosis
- Professional Notes:
- Not an at-home test; professional use
- Whole blood fingerstick CLIA waived
- Storage & Shelf Life Notes:
- Do not freeze. See package insert for expiration dating.
- Manufacturer Links:
- li>LifeSign / Status product page and package insert available from distributor sites
- Moderate complexity for serum/plasma
- SKU:
- 552343
- QTY Per Sell:
- 30
- Number of Tests:
- 30 Tests
- Reading Type:
- Visual Read
- Sample Type:
- Whole Blood / Serum / Plasma Sample
- ic__sync_id:
- 1
- ic__id:
- 1274
- CLIA Classification:
- li>CLIA waived for whole blood
- Moderate complexity for serum/plasma
- Regulatory Status:
- FDA cleared with no age restrictions
- Time To Results:
- 3–8 minutes
- Sample Volume Required:
- 25 µL whole blood; 10 µL serum/plasma
- Test Method:
- Solid-phase chromatographic lateral flow immunoassay
- Kit Contents:
- 30 test devices
- Positive & negative controls
- Developer solution & pipettes
- Storage Temperature:
- Store at 36°–86° F (2–30° C)
- Manufacturer:
- LifeSign (Status™ brand)
- Country of Origin:
- United States
- Intended Use:
- Qualitative detection of heterophile antibodies for IM diagnosis
- Professional Notes:
- Not an at-home test; professional use
- Whole blood fingerstick CLIA waived
- Storage & Shelf Life Notes:
- Do not freeze. See package insert for expiration dating.
- Manufacturer Links:
- li>LifeSign / Status product page and package insert available from distributor sites
- Moderate complexity for serum/plasma
