HbA2 & HbF & HbA1c Assay Kit (HPLC)

Trade name

HbA2 & HbF & HbA1c Assay Kit (HPLC)

06977125152409

B-06977125152409

Reference / catalog number

GHD100

GS1

IVDD — General

Applicable legislation

IVDD [Directive 98/79/EC on in vitro diagnostic medical devices]

Status

On the market

Quantity

1

Additional product description

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.

Additional information URL

No additional information URL provided by the manufacturer.

Clinical sizes

No clinical sizes registered for this device.

European Medical Device Nomenclature — the EU product classification assigned to this device.

• W0103010299OTHER HAEMOGLOBIN (TYPES) TESTING - OTHER