Neonatal Galactose ELISA Kit (with membrane)

Neonatal Galactose ELISA Kit (with membrane)

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SKU 07553303-CF
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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
Trade Name ImmuChem
Usage Statement FDA cleared for In Vitro Diagnostic (IVD) use in the United States. CE Marked for IVD use outside the United States.