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European Diagnostic Manufacturers Association EDMA Classification & Groupings Version 7 - EDMA Classification Overview level 1 & 2 November 2007.

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Presentation on theme: "European Diagnostic Manufacturers Association EDMA Classification & Groupings Version 7 - EDMA Classification Overview level 1 & 2 November 2007."— Presentation transcript:

1 European Diagnostic Manufacturers Association EDMA Classification & Groupings Version 7 - EDMA Classification Overview level 1 & 2 November 2007

2 2 EDMA IVD Classification 6 Total IVD Market 1 Reagents 11 Clinical Chemistry 12 Immuno- chemistry 13 Hematology 14 Microbiology Culture 15 Infectious Immunology 16 Genetic Testing 250 Instruments / Consumables / After Sales / Software 2 Instruments / Consumables 3 After Sales 4 Supporting Software 5 Sample Containers

3 3 EDMA IVD Classification - Reagents 1 Reagents 11 Clinical Chemistry Enzymes Substrates Electrolytes Electrodes & Biosensors Multiple Parameters Controls/Standa rds/ Calibrators Rapid Tests & POC Other Clinical CHemistry 12 Immunochemist ry Specific Proteins Allergy Tumour Markers Tyroid Function Hormones Fertility / Pregnancy Hormones Individual & Specific Hormones Anemia Related / Vitamin Tests Therapeutic Drug Monitoring Drugs of Abuse Auto- Immune Diseases Rheumatoid – Inflammatory Disease Markers Specific Organ Function Assays Cardiac Markers Multiple Parameters Controls/Standa rds/ Calibrators Rapid Tests Other Immunochemist ry 13 Hematology Hematology Reagents Haemostasis Reagents Immunohaemat ology Tissue Typing Reagents Monoclonal Antibodies Cytokines / Immunmodulato rs Histology / Cytology Reagents Other Hematology

4 4 EDMA IVD Classification - Reagents 1 Reagents 14 Microbiology Culture Bacteriology - Culture Bacteriology – Identification &Susceptibility Testing Viral Culture Parasitology Controls/Standards/Calibra tors Rapid Tests Other Microbiology 15 Infectious Immunology 15.01Bacteriology Hepatitis Viruses Retroviruses Other Virology Parasitology Mycology Multiple Parameters Controls/Standards/Calibra tors Rapid Tests Other Infectious Immunology 16 Genetic Testing Inborn Gene or Chromosome Alterations Acquired Gene or Chromosome Alterations Multiple Parameters Other Genetic Tests

5 5 EDMA Groupings - Reagents 1 Reagents 11 Clinical Chemistry 110 Clin Chem excl rapid & POC 111 Clin Chem Reagents Excl Rapid & Controls 12 Immunochemistry 120 Endocrinology Testing 12 04, 05, 06, Proteins 12 01, Hematology 130 Hematology Reagents Excl Controls 131 Hemostasis Reagents Excl Rapid & Controls 132 Immunohematology Reagents Excl Controls 133 Cell Counting 14 Microbiology Culture 140 Bacteriology Culture Excl Blood Culture 142 Other Culture tests 15 Infectious Immunology 150 Other IDD 15 06, 30, IDD excl NA 152 Chlamydia 153 Bacteriology 154 HBV 155 HCV 156 Total Hepatitis 157 Retrovirus 158 Other Virology Excl NA

6 6 EDMA IVD Classification - Instruments 6 Total IVD Market 250 Instruments / Consumables / After Sales / Software 2 Instruments / Consumables 21 Chemistry / Immunochemistry Instruments 23 Haematology / Histology Cytology Instruments 24 Microbiology Instruments 26 Nucleic Acid Testing Instruments 27 Micro-Array Instruments 28 Sample Processing Systems 29 Other Instruments 3 After Sales 31 After Sale Services 32 Spare Parts 4 Supporting Software Supporting Software 5 Sample Containers 51 Dedicated Sample Containers

7 7 EDMA Groupings Reagents & Instruments 6 Total IVD Market 220 Clin. Chem / Immunochem Lab R & I 221 Clin. Chem. Lab R & I 222 Immunochem. Lab R & I 223 Clin. Chem. / RT & POC R & I 224 Hematology R & I 225 Haemostasis R & I 226 Haemostasis RT R & I 227 Immuno- haematology BG R & I 228 Flow Cytometry R & I 229 Histology / Cytology R & I 230 Microbiol. Susc / Ident. R & I 231 Blood Culture Mycobac. R & I 232 Nucleic Acid Test. R & I

8 8 EDMA Groupings - Lab 900 Lab Market 210, 3, 4, Lab Reagents 1 excl Immunochem / IA Lab Reagent Excl Rapid & POC, NAT 940 Molecular Reagents 15 40, Total NA Reagents 1541 Bacteriology NA 1542 Hepatitis NA 1543 Retrovirus NA 1544 Other Virology NA 1547 HCV/HIV NA 1549 Supplement NA 950 Standards / Calibrators Controls XX Lab Instruments 2X XX 10

9 9 EDMA Groupings – Rapid/POC 980 Rapid Test & POC Market 970, Rapid Test Reagents & POC XX Self Testing Reagents & Rapid Test Instruments 2X 07 10


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