Transcript Folie 1

EDMA Classification
& Groupings
European Diagnostic Manufacturers Association
Version 7 - EDMA Classification
Overview level 1 & 2
November 2007
EDMA IVD Classification
6
Total IVD
Market
250
Instruments /
Consumables /
After Sales /
Software
1
Reagents
11
Clinical
Chemistry
12
Immunochemistry
2
13
Hematology
14
Microbiology
Culture
15
Infectious
Immunology
16
Genetic
Testing
2
Instruments /
Consumables
3
After Sales
5
Sample
Containers
4
Supporting
Software
EDMA IVD Classification - Reagents
1
Reagents
11
Clinical Chemistry
12
Immunochemistry
13
Hematology
11.01 Enzymes
12.01 Specific Proteins
13.01 Hematology Reagents
11.02 Substrates
12.02 Allergy
13.02 Haemostasis Reagents
11.03 Electrolytes
12.03 Tumour Markers
13.03 Immunohaematology
11.04 Electrodes & Biosensors
12.04 Tyroid Function Hormones
13.04 Tissue Typing Reagents
11.30 Multiple Parameters
12.05 Fertility / Pregnancy Hormones
13.05 Monoclonal Antibodies
11.50 Controls/Standards/
Calibrators
12.06 Individual & Specific Hormones
13.06 Cytokines / Immunmodulators
11.70 Rapid Tests & POC
12.07 Anemia Related / Vitamin Tests
13.07 Histology / Cytology
Reagents
11.90 Other Clinical CHemistry
12.08 Therapeutic Drug Monitoring
13.90 Other Hematology
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/Standards/
Calibrators
12.70 Rapid Tests
3
12.90 Other Immunochemistry
EDMA IVD Classification - Reagents
1
Reagents
14 Microbiology
Culture
15 Infectious
Immunology
16 Genetic
Testing
14.01 Bacteriology - Culture
15.01Bacteriology
16.01 Inborn Gene or
Chromosome Alterations
14.02 Bacteriology –
Identification &Susceptibility Testing
15.02 Hepatitis Viruses
16.02 Acquired Gene or
Chromosome Alterations
14.04 Viral Culture
15.03 Retroviruses
16.30 Multiple Parameters
14.05 Parasitology
15.04 Other Virology
16.90 Other Genetic Tests
14.50 Controls/Standards/Calibrators
15.05 Parasitology
14.70 Rapid Tests
15.06 Mycology
14.90 Other Microbiology
15.30 Multiple Parameters
15.3
15.50 Controls/Standards/Calibrators
15.70 Rapid Tests
4
15.90 Other Infectious Immunology
EDMA Groupings - Reagents
1
Reagents
11
Clinical
Chemistry
12
Immunochemistry
13
Hematology
14
Microbiology Culture
15
Infectious Immunology
110
Clin Chem
excl rapid & POC
120
Endocrinology
Testing
12 04, 05, 06, 07
130
Hematology
Reagents
Excl Controls
140
Bacteriology Culture
Excl Blood Culture
150
Other IDD
15 06, 30, 90
111
Clin Chem
Reagents
Excl Rapid & Controls
121
Proteins
12 01, 12 11
131
Hemostasis
Reagents
Excl Rapid & Controls
142
Other Culture tests
151
IDD excl NA
132
Immunohematology
Reagents
Excl Controls
5
133
Cell Counting
152 Chlamydia
153 Bacteriology
154 HBV
155 HCV
156 Total Hepatitis
157 Retrovirus
158 Other Virology
Excl NA
EDMA IVD Classification - Instruments
6 Total IVD
Market
250
Instruments / Consumables /
After Sales / Software
2 Instruments /
Consumables
21 Chemistry / Immunochemistry
Instruments
31 After Sale Services
23 Haematology / Histology
Cytology Instruments
32 Spare Parts
26 Nucleic Acid Testing
Instruments
27 Micro-Array Instruments
28 Sample Processing Systems
29 Other Instruments
6
4 Supporting
Software
3 After Sales
24 Microbiology Instruments
5 Sample Containers
51 Dedicated Sample Containers
Supporting Software
EDMA Groupings Reagents & Instruments
6
Total IVD
Market
220
Clin. Chem /
Immunochem
Lab R & I
223
Clin. Chem. /
RT & POC
R&I
221
Clin. Chem.
Lab R & I
222
Immunochem.
Lab R & I
7
224
Hematology
R&I
225
Haemostasis
R&I
227
Immunohaematology
BG R & I
226
Haemostasis RT
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
EDMA Groupings - Lab
900
Lab Market
210, 3, 4, 910
810
Immunochem / IA Lab Reagent
Excl Rapid & POC, NAT
910
Lab Reagents
1 excl 970
210
Lab Instruments
2X XX 10
940
Molecular Reagents
15 40, 16
950
Standards / Calibrators
Controls
XX 50
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
8
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
9
217
Rapid Test Instruments
2X 07 10