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HbA1c controls and calibrators 
for diabetes testing

The Hemoglobin A1c control is available in lyophilised or

liquid form, and is a two level control with defined levels between 4.5% – 6.0% (Normal, Level 1) and between 9.0% – 13.0% (Abnormal, Level 2). They are intended as a quality control material for analytical methods including ion exchange HPLC, immunoassay and boronate affinity for quantitation of HbA1c.

The source blood is tested as non-reactive for Hepatitis B surface antigen, Hepatitis C antibody, antibodies against human immunodeficiency virus (HIV) types 1 & 2, HIV-1 antigen, and Syphilis (RPR or TPHA).

The controls are in glass vials with screw top caps.  Each vial is reconstituted with 0.25ml (lyophilised) or 1.0mL (liquid) to give

a typical hemoglobin concentration of 14g/dL. The lyophilised product is stable for 3 years from manufacture with 3 months

for the reconstituted control stored at 2° to 8°C.  The liquid product has a closed vial life of 30 months and an open vial life of 30 days when stored at 2° – 8°C.  There is no need to

aliquot and freeze in order to extend the shelf life.

These controls are listed with US FDA and are CE-Marked.

Available in 4 Vial, 24 Vial and bulk kits.

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Contact us for more information.

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