Product Details
The NGAL Test is a quantitative particle-enhanced
turbidimetric immunoassay designed to run on automated chemistry analyzers.
Pending FDA 510(k) clearance.
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| The NGAL Reagent Kit Specifications | |
|---|---|
| Test Method | Particle-enhanced turbidimetric immunoassay (PETIA) |
| Kit Contains | Catalog Number: ST001RA R1: Ready to use NGAL Buffer Solution (1 x 35 mL) R2: NGAL latex suspension (1 x 7 mL) Instructions for Use |
| Sample Type | Urine or Plasma |
| Sample Analysis Time | Approximately 10 minutes (varies by analyzer) |
| Measuring Range | Depends on analyzer used |
| Number of Tests per Kit | Depends on analyzer used |
| Storage | Store at 2-8°C. Do not freeze |
| Shelf Life | 24 months (from production), see expiration date on the label |
| Regulatory Status | Pending FDA 510(k) clearance in the United States for in vitro diagnostics use. For IVD use in the European Union, Korea and Israel only. Visit bioporto.com for CE product ordering information. |
| Patent Status | This product is protected by one or more US, European and/or foreign patents. |
| The NGAL Test: Calibrators and Controls | |
|---|---|
| Calibrator Kit | For establishing the calibration curve. Catalog number: ST002RA
Contains: 5 vials (1mL each) of ready-to-use solution Store at 2-8°C. Do not freeze. |
| Control Kit | To validate the calibration curve.
Catalog number: ST003RA
Quality Control Material (ready-to-use solution): • High Control: 3 x 1mL • Low Control: 3 x 1mL Store at 2-8°C. Do not freeze. |