Neonatal Galactose ELISA Kit (with membrane)
Description
Product Description
The Neonatal Galactose ELISA is designed for the quantitative determination of galactose in neonatal blood spots. It is for in vitro diagnostic use as an aid in screening newborns for elevated galactose levels as seen in galactosemia.
Usage Statement
FDA cleared for In Vitro Diagnostic (IVD) use in the United States. CE Marked for IVD use outside the United States.
Key Applications
Newborn Screening
Specifications
| SKU | 07553303-CF |
| Analyte / Target | Galactose |
| Diagnostic Platforms | EIA/ELISA |
| Diagnostic Solutions | Newborn Screening |
| Disease Screened | Galactose |
| Evaluation | Quantitative |
| Applications | Newborn Screening |
| Kit or Assay Type | Competitive Enzyme Immunoassay |
| Presentation | with membrane |
| Product Families Description | The Neonatal Galactose ELISA is designed for the quantitative determination of galactose in neonatal blood spots. It is for in vitro diagnostic use as an aid in screening newborns for elevated galactose levels as seen in galactosemia. |
| Product Overview | The kit is ready to use and includes the following components: Membrane Transfer Plate, Collection-Reaction Plate, 5 Standards, 3 Controls, TCA Extraction Solution, Neutralizing Solution, Reagent A and Reagent B. |
| Recommended Replacement For | 07553303 | 07553300 | 07553306 |
| Regulatory Compliance | FDA Cleared (K951329S2) |
| Sample Type | Dried Blood Spot |
| Sample Volume | 2 x 3.2 mm (1/8”) or 4.7 mm (3/16”) dried blood spot|5 uL Whole Blood |
| Species Reactivity | human |
| Standards | Assigned values. Refer to kit calibrator labels |
| Storage and Handling | Store at 2 - 8C |
| Usage Statement | FDA cleared for In Vitro Diagnostic (IVD) use in the United States. CE Marked for IVD use outside the United States. |