You are here

Conformity assessment procedures for immunohaematology reagents

Version 1.0, February 2012

29 February 2012

Book pagination

GMDN codes for immunohaematology reagents

The GMDN is an international nomenclature system used by regional or national regulatory bodies to consistently describe medical devices, and selection of an appropriate GMDN code is required when submitting an application to include medical devices in the ARTG.

Regulation 1.7 specifies certain device nomenclature codes that must be used for IVD medical devices, depending on their risk classification:

  1. for a Class 4 IVD medical device - the relevant preferred term;
  2. for a Class 4 IVD medical device that is an immunohaematology reagent IVD medical device - the relevant Level 2 collective term;
  3. for a Class 3 IVD medical device - the relevant Level 3 collective term, or if no Level 3 collective term exists, the relevant Level 2 collective term;
  4. for a Class 2 IVD medical device - the relevant Level 2 collective term;
  5. for a Class 1 IVD medical device or an export only IVD medical device - the relevant Level 1 collective term.

In practical terms, there are six Level 2 Collective Terms (L2CT) which are applicable to Class 3 or Class 4 IHRs:

  • CT887 Immunohaematology blood grouping antisera IVDs
  • CT890 Immunohaematology calibrator/control IVDs
  • CT1270 Immunohaematology-related IVDs
  • CT888 Immunohaematology sensitised cell-typing IVDs
  • CT753 Multiple blood grouping and typing IVDs
  • CT886 Reagent red blood cell IVDs

Book pagination