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 MethodParticle-enhanced turbidimetric immunoassay (PETIA)
RUO Kit ContainsCatalog 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 TypeUrine or Plasma
Sample Analysis TimeApproximately 10 minutes (varies by analyzer)
Measuring RangeDepends on analyzer used
Number of Tests per KitDepends on analyzer used
StorageStore at 2-8°C. Do not freeze
Shelf Life24 months (from production), see expiration date on the label
Regulatory StatusIn the US: for research use only, not for use with diagnostic procedures; pending FDA 510(k) clearance. For IVD use in the European Union, Korea and Israel only. Visit bioporto.com for CE product ordering information.
Patent StatusThis product is protected by one or more US, European and/or foreign patents.
The NGAL Test: Calibrators and Controls
Calibrator KitFor 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 KitTo 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.