Device Dossier
Red cell metabolic enzyme IVDs
Device Dossier for Red cell metabolic enzyme IVDs (CT285 - Red cell metabolic enzyme IVDs, Class 3, sponsor Biocelect). ARTG record, intended purpose,…
- GMDN category: CT285 - Red cell metabolic enzyme IVDs
- Sponsor: Biocelect
Intended purpose
The STANDARD G6PD Test is an in vitro enzymatic colorimetric method for the semi-quantitative measurement of total hemoglobin concentration and G6PD enzymatic activity in a human fresh whole blood specimen. The test is intended to aid in the identification of people with G6PD deficiency, providing point-of-care access and allowing prompt treatment decisions. The STANDARD G6PD Test has not been validated for use with neonatal samples. This STANDARD G6PD Test is for professional use only. Specimens that generate deficient results should be considered with other clinical history available to the physician and confirmatory test methods to verify the deficiency.