HbA2 & HbF & HbA1c Assay Kit (HPLC)

Dénomination commerciale

HbA2 & HbF & HbA1c Assay Kit (HPLC)

06977125152416

B-06977125152416

Numéro de référence/catalogue

GHD200

GS1

IVDD — Général

Législation applicable

IVDD [Directive 98/79/CE relative aux dispositifs médicaux de diagnostic in vitro]

Statut

Sur le marché

Quantité

1

Description complémentaire du produit

HbA2 & HbF &HbA1c Assay Kit (HPLC), when used in conjunction with GSH-60/GSH-50 Automatic HPLC HbA1c Analyzer (hereafter referred to as GSH-60/GSH-50 Analyzer), is intended for in vitro diagnostic use for the quantitative determination of Hemoglobin A2 (HbA2), Fetal Hemoglobin (HbF) and Hemoglobin A1c (HbA1c) in human whole blood. β-thalassemia carriers are often asymptomatic or have mild anemia. When both parents are carriers, each pregnancy has a 25% risk of a child with transfusion-dependent β-thalassemia. β-thalassemia carriers may present with mild anemia or no symptoms, but their offspring may inherit the homozygous form, which causes severe anemia, jaundice, splenomegaly, bone deformities, growth retardation, and often premature death. Identifying carriers is therefore clinically important. In adults, blood hemoglobin consists mainly of hemoglobin A (HbA), with smaller amounts of HbA2 and HbF. Carriers typically have HbA2 ≥ 3.5% and HbF ≥ 2.0%. Measurement of HbA2 and HbF therefore can assist in the diagnosis of β-thalassemia. Measurement of HbA1c provides a marker of the average blood glucose level over the preceding 2–3 months and is widely used in the diagnosis and management of diabetes mellitus.

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Dimensions cliniques

Aucune dimension clinique enregistrée pour ce dispositif.

Nomenclature européenne des dispositifs médicaux — la classification produit UE attribuée à ce dispositif.

• W0103010299OTHER HAEMOGLOBIN (TYPES) TESTING - OTHER