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 11.01 Enzymes 11.02 Substrates 11.03 Electrolytes 11.04 Electrodes & Biosensors 11.30 Multiple Parameters 11.50 Controls/Standa rds/ Calibrators 11.70 Rapid Tests & POC 11.90 Other Clinical CHemistry 12 Immunochemist ry 12.01 Specific Proteins 12.02 Allergy 12.03 Tumour Markers 12.04 Tyroid Function Hormones 12.05 Fertility / Pregnancy Hormones 12.06 Individual & Specific Hormones 12.07 Anemia Related / Vitamin Tests 12.08 Therapeutic Drug Monitoring 12.09 Drugs of Abuse 12.10 Auto- Immune Diseases 12.11 Rheumatoid – Inflammatory Disease Markers 12.12 Specific Organ Function Assays 12.13 Cardiac Markers 12.30 Multiple Parameters 12.50 Controls/Standa rds/ Calibrators 12.70 Rapid Tests 12.90 Other Immunochemist ry 13 Hematology 13.01 Hematology Reagents 13.02 Haemostasis Reagents 13.03 Immunohaemat ology 13.04 Tissue Typing Reagents 13.05 Monoclonal Antibodies 13.06 Cytokines / Immunmodulato rs 13.07 Histology / Cytology Reagents 13.90 Other Hematology

4. 4 EDMA IVD Classification - Reagents 1 Reagents 14 Microbiology Culture 14.01 Bacteriology - Culture 14.02 Bacteriology – Identification &Susceptibility Testing 14.04 Viral Culture 14.05 Parasitology 14.50 Controls/Standards/Calibra tors 14.70 Rapid Tests 14.90 Other Microbiology 15 Infectious Immunology 15.01Bacteriology 15.02 Hepatitis Viruses 15.03 Retroviruses 15.04 Other Virology 15.05 Parasitology 15.06 Mycology 15.315.30 Multiple Parameters 15.50 Controls/Standards/Calibra tors 15.70 Rapid Tests 15.90 Other Infectious Immunology 16 Genetic Testing 16.01 Inborn Gene or Chromosome Alterations 16.02 Acquired Gene or Chromosome Alterations 16.30 Multiple Parameters 16.90 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, 07 121 Proteins 12 01, 12 11 13 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, 90 151 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, 910 910 Lab Reagents 1 excl 970 810 Immunochem / IA Lab Reagent Excl Rapid & POC, NAT 940 Molecular Reagents 15 40, 16 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 50 210 Lab Instruments 2X XX 10

9. 9 EDMA Groupings – Rapid/POC 980 Rapid Test & POC Market 970, 217 970 Rapid Test Reagents & POC XX 70 971 Self Testing Reagents 11 70 01 01 & 12 70 05 02 217 Rapid Test Instruments 2X 07 10