Immunohaematology calibrator/control IVDs

Land: Australien

Språk: engelska

Källa: Department of Health (Therapeutic Goods Administration)

Tillgänglig från:

Grifols Australia Pty Ltd

Klass:

Class 4

Tillverkad av:

Medion Grifols Diagnostics AG Bonnstrasse 9, DUDINGEN, CH3186 Switzerland

Terapiområde:

CT890 - Immunohaematology calibrator/control IVDs

Terapeutiska indikationer:

Immunohematology calibrators are intended to allow regular control of materials, work procedures and instrument procedures for (i) the determination of the ABO, Rhesus and K antigens, (ii) the determination of the appropriate ABO blood group antibodies and (iii) the detection of irregular antibodies in both antiglobulin and enzyme technique. The product is suitable for use with DG Gel technique, MDmulticard and conventional tube technique Immunohematology calibrator are intended to allow regular control of materials, work procedures and instrument procedures for (i) the determination of the ABO, Rhesus and K antigens, (ii) the determination of the appropriate ABO blood group antibodies and (iii) the detection of irregular antibodies in both antiglobulin and enzyme technique. The product is suitable for use with DG Gel technique, MDmulticard and conventional tube technique.

Bemyndigande status:

A

Tillstånd datum:

2020-11-11