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Bringing Value-Added Efficiency
To Your Laboratory
Diametra is dedicated to providing quality products and the highest level of service in its target diagnostics segments. Through innovation and total commitment we strive to create value for our people, customers and shareholders.
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Our Product Portfolio
Steroid Hormones
Diabetes Monitoring
Cost-Effective Solutions for your Laboratory.All DiaMetra immunoassay kits in 96 breakable well format.
Miscellaneous
Thyroid Monitoring
5
Steroid Hormones in serumProduct
CodeProduct Description Size Certification
17-OH ProgesteroneQuantitative immunoenzymatic determination of 17-OH Progesterone
Sample Type • Serum, plasma
DKO 004
96 Wells
CESample Volume • 25 µL
Sensitivity • 0.05 ng/mL
CortisolQuantitative immunoenzymatic determination of Cortisol
Sample Type • Serum, plasma
DKO 001
96 Wells
CESample Volume • 20 µL
Sensitivity • 2.44 ng/mL
Urinary CortisolQuantitative immunoenzymatic determination of free Cortisol in urine
Sample Type • Urine
DKO 018
96 Wells
CESample Volume • 10 µL
Sensitivity • 2.95 ng/mL
TestosteroneQuantitative immunoenzymatic determination of Total Testosterone
Sample Type • Serum, plasma
DKO 002
96 Wells
CESample Volume • 25 µL
Sensitivity • 0.10 ng/mL
Free TestosteroneQuantitative immunoenzymatic determination of Free Testosterone
Sample Type • Serum, plasma
DKO 015
96 Wells
CESample Volume • 20 µL
Sensitivity • 0.04 pg/ml
AndrostenedioneQuantitative immunoenzymatic determination of Δ4-Androstenedione
Sample Type • Serum, plasma
DKO 008
96 Wells
CESample Volume • 25 µL
Sensitivity • 0.01 ng/mL
Steroid Hormones in serumProduct
CodeProduct Description Size Certification
ProgesteroneQuantitative immunoenzymatic determination of Progesterone
Sample Type • Serum, plasma
DKO 006
96 Wells
CESample Volume • 20 µL
Sensitivity • 0.05 ng/mL
EstradiolQuantitative immunoenzymatic determination of 17β-Estradiol
Sample Type • Serum, plasma
DKO 003
96 Wells
CESample Volume • 25 µL
Sensitivity • 8.68 pg/mL
DHEA-SQuantitative immunoenzymatic determination of Dehydroepiandrosterone sulfate
Sample Type • Serum, plasma
DKO 005
96 Wells
CESample Volume • 30 µL
Sensitivity • 0.03 µg/mL
Free EstriolDirect immunoenzymatic determination of Free Estriol
Sample Type • Serum, plasma
DKO 007
96 Wells
CESample Volume • 25 µL
Sensitivity • 0.03 ng/mL
Total EstriolQuantitative immunoenzymatic determination of Total Estriol
Sample Type • Serum, plasma
DKO 019
96 Wells
CESample Volume • 20 µL
Sensitivity • 0.22 ng/mL
DHEAQuantitative immunoenzymatic determination of Dehydroepiandrosterone
Sample Type • Serum, plasma
DKO 124
96 Wells
CESample Volume • 25 µL
Sensitivity • 0.10 ng/mL
SHBGQuantitative immunoenzymatic determination of SHBG (Sex Hormone Binding Globulin)
Sample Type • Serum, plasma
DKO 087
96 Wells
CESample Volume • 25 µL
Sensitivity • 0.2 nmol/l
4
KEY: CE = CE Marked RUO = Research Use Only
6
Steroid in salivaProduct
CodeProduct Description Size Certification
Cortisol salivaQuantitative direct immunoenzymatic determination of Cortisol in saliva
Sample Type • Saliva
DKO 020
96 Test
CESample Volume • 25 µL
Sensitivity • 0.12 ng/mL
Testosterone salivaQuantitative direct immunoenzymatic determination of Testosterone in saliva
Sample Type • Saliva
DKO 021
96 Test
CESample Volume • 100 µL
Sensitivity • 3.0 pg/mL
Estradiol salivaQuantitative direct immunoenzymatic determination of Estradiol in saliva
Sample Type • Saliva
DKO 022
96 Test
CESample Volume • 100 µL
Sensitivity • 0.5 pg/mL
DHEA-S salivaQuantitative direct immunoenzymatic determination of DHEA-S in saliva
Sample Type • Saliva
DKO 024
96 Test
CESample Volume • 50 µL
Sensitivity • 0.05 ng/mL
Progesterone salivaQuantitative direct immunoenzymatic determination of Progesterone in saliva
Sample Type • Saliva
DKO 025
96 Test
CESample Volume • 100 µL
Sensitivity • 3.8 pg/mL
Steroid in urineProduct
CodeProduct Description Size Certification
AldosteroneQuantitative direct immunoenzymatic determination of Aldosterone in serum
Sample Type • Serum, Plasma or Urine
DKO 053
96 Test
CESample Volume • 50 µL
Sensitivity • 7.0 pg/mL
7
Steroid in salivaProduct
CodeProduct Description Size Certification
Estriol salivaQuantitative direct immunoenzymatic determination of Estriol in saliva
Sample Type • Saliva
DKO 026
96 Test
CESample Volume • 50 µL
Sensitivity • < 2.0 pg/m
Androstenedione salivaQuantitative direct immunoenzymatic determination of Androstenedione in saliva
Sample Type • Saliva
DKO 027
96 Test
CESample Volume • 50 µL
Sensitivity • 5.0 pg/mL
Estriol saliva HS Quantitative direct immunoenzymatic determination of Estriol in saliva
Sample Type • Saliva
DKO 178
96 Test
CESample Volume • 200 µL
Sensitivity • 1.48 pg/mL
Saliva MiscellaneousProduct
CodeProduct Description Size Certification
Salivari IgA Quantitative direct immunoenzymatic determination of IgA in saliva
Sample Type • Saliva
DKO 078
96 Test
CESample Volume • 25 µL
Sensitivity • 0.5 µg/mL
Saliva Collector devicesMethod for collection of saliva samples using the glass collection device
Sample Type • Saliva
DKO 063
100Pieces
CESample Volume • N/A
Sensitivity • N/A
Salivette (Sarsted)Method for collection of saliva samples using the plastic collection device
Sample Type • Saliva
DKO 120
100Pieces
CESample Volume • N/A
Sensitivity • N/A
KEY: CE = CE Marked RUO = Research Use Only
8 9
GrowthProduct
CodeProduct Description Size Certification
IGF-1Quantitative immunoenzymatic determination of human Insulin-like Growth Factor 1 (IGF-1)
Sample Type • Serum
DKO 186
96 Wells
CESample Volume • 50 µL
Sensitivity • 7.8 ng/mL
hGH ELISAQuantitative immunoenzymatic determination of human Growth Hormone
Sample Type • Serum or Plasma
DKO 050
96 Wells
CESample Volume • 50 µL
Sensitivity • 0.105 IU/mL
Thyroid MonitoringProduct
CodeProduct Description Size Certification
TSH Receptors AbQuantitative immunoenzymatic determination of Thyrotropin Receptor Autoantibodies (TRAb)
Sample Type Serum
DKO 085
96 Wells
CESample Volume 75 µL
Sensitivity 0.21 U/mL
Anti-TPOQuantitative immunoenzymatic determination of antibodies against Thyroperoxidase (TPO)
Sample Type • Serum, Plasma
DKO 116
96 Wells
CESample Volume • 100 µL
Sensitivity • 0.09 AU/mL
Anti-TGQuantitative immunoenzymatic determination of antibodies against Thyroglobulin (TG)
Sample Type • Serum, Plasma
DKO 115
96 Wells
CESample Volume • 100 µL
Sensitivity • 0.11 AU/mL
ThyroglobulinQuantitative immunoenzymatic determination of Thyroglobulin
Sample Type • Serum
DKO 048
96 Wells
CESample Volume • 50 µL
Sensitivity • 0.44 ng/mL
TSHDirect immunoenzymatic determination of TSH in human serum or plasma
Sample Type • Serum, Plasma
DKO 013
96 Test
CESample Volume • 50 µL
Sensitivity • 0.01 mIU/mL
Thyroid MonitoringProduct
CodeProduct Description Size Certification
FT3Direct immunoenzymatic determination of Free Triiodothyronine (FT3) in human serum or plasma.
Sample Type • Serum, Plasma
DKO 037
96 Test
CESample Volume • 50 µL
Sensitivity • 0.05 pg/mL
FT4Direct immunoenzymatic determination of Free Thyroxine (FT4) in human serum or plasma.
Sample Type • Serum, Plasma
DKO 038
96 Test
CESample Volume • 50 µL
Sensitivity • 0.05 ng/dL
T3Direct immunoenzymatic determination of Triiodothyronine (T3) in human serum or plasma.
Sample Type • Serum, Plasma
DKO 044
96 Test
CESample Volume • 50 µL
Sensitivity • 5.0 ng/dL
T4Direct immunoenzymatic determination of Thyroxine (T4) in human serum or plasma.
Sample Type • Serum, Plasma
DKO 045
96 Test
CESample Volume • 25 µL
Sensitivity • 0.4 µg/dL
Saliva Miscellaneous Product
CodeProduct Description Size Certification
Saliva ControlFor in vitro diagnostic use in the quality control of immunoassays using saliva samples
Sample Type • Saliva
DKO 067
1x3x2mL
CESample Volume • N/A
Sensitivity • N/A
KEY: CE = CE Marked RUO = Research Use Only
Diabetes MonitoringProduct
CodeProduct Description Size Certification
Fetuin ADirect immunoenzymatic determination of Fetuin A in human serum or plasma
Sample Type • Serum, Plasma
DKO 128
96Test
CESample Volume • 100 µL
Sensitivity • 0.04 ng/mL
Fertility Proteic HormonesProduct
CodeProduct Description Size Certification
LHDirect immunoenzymatic determination of the Luteinizing Hormone (LH) in human serum or plasma.
Sample Type • Serum, Plasma
DKO 009
96 Test
CESample Volume • 20 µL
Sensitivity • 0.22 IU/mL
FSHDirect immunoenzymatic determination of the Follicle-Stimulating Hormon (FSH) in human serum or plasma.
Sample Type • Serum, Plasma
DKO 010
96 Test
CESample Volume • 50 µL
Sensitivity • 0.17 IU/mL
ProlactinDirect immunoenzymatic determination of Prolactin in human serum
Sample Type • Serum
DKO 011
96 Test
CESample Volume • 50 µL
Sensitivity • 0.12 ng/mL
b-HCGDirect immunoenzymatic determination of β-HCG in human serum or plasma
Sample Type • Serum, Plasma
DKO 014
96 Test
CESample Volume • 25 µL
Sensitivity • 0.09 mIU/mL
10 11
Diabetes monitoringProduct
CodeProduct Description Size Certification
InsulinQuantitative immunoenzymatic determination of Insulin
Sample Type • Serum
DKO 076
96 Wells
CESample Volume • 100 µL
Sensitivity • 0.25 µIU/mL
C-PeptideQuantitative immunoenzymatic determination of C-Peptide
Sample Type • Serum
DKO 077
96 Wells
CESample Volume • 50 µL
Sensitivity • 0.01 ng/mL
Anti-GAD Quantitative immunoenzymatic determination of autoantibodies to Glutamic Acid Decarboxylase (GAD)
Sample Type • Serum
DKO 082
96 Wells
CESample Volume • 25 µL
Sensitivity • 0.24 IU/mL
IAAQuantitative immunoenzymatic determination of circulating autoantibodies to human native Insulin
Sample Type • Serum
DKO 083
96 Wells
CESample Volume • 100 µL
Sensitivity • 0.1 U/ml
Anti-IA2Quantitative immunoenzymatic determination of autoantibodies to Protein Tyrosine Phosphatase (IA2)
Sample Type • Serum, Plasma
DKO 084
96 Wells
CESample Volume • 50 µL
Sensitivity • 0.37 IU/mL
ZnT8Ab (only for italian market)Enzyme immunoassay for the quantitative determination of Zinc Transporter 8 (ZnT8) autoantibodies in human serum
Sample Type • Serum
ZnT8Ab96
TestCESample Volume • 25 µL
Sensitivity • N/A
KEY: CE = CE Marked RUO = Research Use Only
HypertensionProduct
CodeProduct Description Size Certification
AldosteroneDirect immunoenzymatic determination of Aldosterone in human serum, human plasma or urine.
Sample Type • Serum, Plasma, Urine
DKO 053
96Test
CESample Volume • 50 µL
Sensitivity • 7.0 pg/mL
ReninImmunoenzymatic determination of Renin concentration in human plasma
Sample Type • Plasma
DKO 150
96Test
CESample Volume • 200 µL
Sensitivity • 0.8 pg/mL
12
Tumour MarkersProduct
CodeProduct Description Size Certification
AFPDirect immunoenzymatic determination of AFP in human serum or plasma
Sample Type • Serum, Plasma
DKO 012
96 Test
CESample Volume • 25 µL
Sensitivity • 0.35 ng/mL
CEADirect immunoenzymatic determination of Carcinoembryonic Antigen (CEA) in human serum or plasma.
Sample Type • Serum, Plasma
DKO 051
96 Test
CESample Volume • 25 µL
Sensitivity • 0.11 ng/mL
CA-125Direct immunoenzymatic determination of CA125 in human serum or plasma.
Sample Type • Serum, Plasma
DKO 054
96 Test
CESample Volume • 25 µL
Sensitivity • 1.7 U/mL
CA 15-3Direct immunoenzymatic determination of CA 15-3 in human serum or plasma
Sample Type • Serum, Plasma
DKO 055
96 Test
CESample Volume • 200 µL
Sensitivity • 0.5 U/mL
13
Tumour MarkersProduct
CodeProduct Description Size Certification
PSADirect immunoenzymatic determination of PSA in human serum or plasma.
Sample Type • Serum, Plasma
DKO 057
96 Test
RUOSample Volume • 25 µL
Sensitivity • 0.5 ng/mL
Free PSADirect immunoenzymatic determination of Free PSA in human serum or plasma.
Sample Type • Serum, Plasma
DKO 064
96 Test
RUOSample Volume • 50 µL
Sensitivity • 0.052 ng/mL
CA 19-9Direct immunoenzymatic determination of CA19-9 in human serum or plasma.
Sample Type • Serum, Plasma
DKO 056
96 Test
CESample Volume • 100 µL
Sensitivity • 0.18 U/mL
hNSEDirect immunoenzymatic determination of hNSE in human serum
Sample Type • Serum
DKO 073
96 Test
CESample Volume • 25 µL
Sensitivity • 0.19 ng/mL
S 100 BDirect immunoenzymatic determination of S100B in human serum or plasma
Sample Type • Serum, Plasma
DKO 074
96 Test
CESample Volume • 50 µL
Sensitivity • 35 pg/mL
Total PSAEnzyme immunoassay for the quantitative determination of Total PSA (Prostata Specific Antigen) in human serum and plasma
Sample Type • Serum, Plasma
DKO 137
96 Test
CESample Volume • 25 µL
Sensitivity • 0.2 ng/mL
Free PSAEnzyme immunoassay for the quantitative determination of Free PSA (Prostata Specific Antigen) in human serum and plasma
Sample Type • Serum, Plasma
DKO 138
96 Test
CESample Volume • 25 µL
Sensitivity • 0.1 ng/mLKEY: CE = CE Marked RUO = Research Use Only
MiscellaneousProduct
CodeProduct Description Size Certification
FerritinDirect immunoenzymatic determination of Ferritin in human serum or plasma
Sample Type • Serum, Plasma
DKO 039
96 Test
CESample Volume • 20 µL
Sensitivity • 0.53 ng/mL
IgE TotalDirect immunoenzymatic determination of Immunoglobulin E (IgE) in human serum or plasma
Sample Type • Serum, Plasma
DKO 060
96 Test
CESample Volume • 25 µL
Sensitivity • 0.27 IU/mL
Troponin IQuantitative Immunoenzymatic determination of Troponin I in human serum
Sample Type • Serum
DKO 180
96 Test
RUOSample Volume • 25 µL
Sensitivity • 0.03 ng/mL
CalcitoninImmunoenzymatic determination of Calcitonin concentration in human serum
Sample Type • Serum
DKO 181
96 Test
RUOSample Volume • 100 µL
Sensitivity • 0.7 pg/mL
14
Tumour MarkersProduct
CodeProduct Description Size Certification
Free B-HCGQuantitative Immunoenzymatic determination of Free b-HCG (free b-subunit Human Chorionic Gonadotropin) in human serum
Sample Type • Serum
DKO 183
96 Test
RUOSample Volume • 25 µL
Sensitivity • 0.019 mIU/mL
PAPP-AQuantitative immunoenzymatic determination of PAPP-A (Pregnancy Associated Plasma Protein A) concentration in human serum.
Sample Type • Serum
DKO 184
96 Test
RUOSample Volume • 10 µL
Sensitivity • 34 mIU/mL
CHROMOGRANIN AQuantitative determination of Chromogranin A in human serum or plasma
Sample Type • Serum, Plasma
TM E 9000
96 Test
CESample Volume • 50 µL
Sensitivity • 12.4 µg/L
15
Circulating ImmunocomplexProduct
CodeProduct Description Size Certification
CIC C1qDirect immunoenzymatic determination of CIC C1q in human serum or plasma
Sample Type • Serum, Plasma
DKO 016
96 Test
CESample Volume • 100 µL
Sensitivity • 1.0 µg Equiv/mL
CIC C3dDirect immunoenzymatic determination of Circulating Immune Complex C3d (CIC C3d) in human serum or plasma
Sample Type • Serum, Plasma
DKO 017
96 Test
CESample Volume • 100 µL
Sensitivity • 1.0 µg Equiv/mL
CH50FUNCTIONALITY TEST OF COMPLEMENT (CH 50)
Sample Type • Serum
DKO 040
96 Test
CESample Volume • 50 µL
Sensitivity • N/A
Calcium MetabolismProduct
CodeProduct Description Size Certification
25 OH Vitamin DQuantitative immunoenzymatic determination of 25OH Vitamin D concentration in human serum and plasma
Sample Type • Serum, Plasma
DKO 146
96Test
CESample Volume • 10 µL
Sensitivity • 0.67 ng/mL
KEY: CE = CE Marked RUO = Research Use Only
16
KEY: CE = CE Marked RUO = Research Use Only
Autoimmunity: GastroenterologyProduct
CodeProduct Description Size Certification
Anti Deamidated Gliadin Peptides (DGP) IgGQuantitative determination of IgG class antibodies against Deamidated Gliadin Peptide (DGP) in human serum or plasma
Sample Type • Serum, Plasma
DKO 106
96Test
CESample Volume • 100 µL
Analytical sensitivity • 0.13 AU/mL
Anti Deamidated Gliadin Peptides (DGP) IgAQuantitative determination of IgA class antibodies against Deamidated Gliadin Peptides (DGP) in human serum or plasma
Sample Type • Serum, Plasma
DKO 107
96Test
CESample Volume • 100 µL
Analytical sensitivity • 0.74 AU/mL
Anti Transglutaminase IgAEnzyme Immunoassay for the quantitative determination of IgA autoantibodies against Tissue Transglutaminase
Sample Type • Serum, Plasma
DKO 140
96Test
CESample Volume • 100 µL
Analytical sensitivity • 1.0 AU/mL
Anti Transglutaminase IgGEnzyme Immunoassay for the quantitative determination of IgG autoantibodies against Tissue Transglutaminase
Sample Type • Serum, Plasma
DKO 141
96Test
CESample Volume • 100 µL
Analytical sensitivity • 1.0 AU/mL
17
Autoimmunity: ThrombosisProduct
CodeProduct Description Size Certification
Anti Beta 2 Glycoprotein 1 IgMQuantitative determination of IgM class antibodies against ββ-Glicoprotein 1 in human serum or plasma
Sample Type • Serum, Plasma
DKO 111
96 Test
CESample Volume • 100 µL
Analytical sensitivity • 9 0.11 AU/mL
Anti Cardiolipin IgMQuantitative determination of IgM autoantibodies against Cardiolipina in human serum or plasma
Sample Type • Serum, Plasma
DKO 112
96 Test
CESample Volume • 100 µL
Analytical sensitivity • 0.12 AU/mL
Anti Cardiolipin IgGQuantitative determination of IgG autoantibodies against Cardiolipina in human serum or plasma
Sample Type • Serum, Plasma
DKO 113
96 Test
CESample Volume • 100 µL
Analytical sensitivity • 0.08 AU/mL
Anti Phospholipid ScreenQuantitative determination of auto-antibodies against Phospholipids in human serum or plasma
Sample Type • Serum, Plasma
DKO 114
96 Test
CESample Volume • 100 µL
Analytical sensitivity • IgG= 0.3 AU/mL; IgM= 0.16 AU/mL
Anti Cardiolipin ScreenQuantitative determination of IgG or IgM autoantibodies against Cardiolipin in human serum or plasma
Sample Type • Serum, Plasma
DKO 144
96 Test
CESample Volume • 100 µL
Analytical sensitivity • IgG= 0.8 AU/mL
Anti Beta 2 Glycoprotein 1 ScreenQuantitative determination of IgG o IgM class antibodies against ββ-Glicoprotein 1 in human serum or plasma.
Sample Type • Serum, Plasma
DKO 145
96 Test
CESample Volume • 100 µL
Analytical sensitivity • 0.47 AU/mL
Autoimmunity: ThrombosisProduct
CodeProduct Description Size Certification
CalcitoninQuantitative determination of IgG o IgM class antibodies against ββ-Glicoprotein 1 in human serum or plasma.
Sample Type • Serum, Plasma
DKO 145
96 Test
RUOSample Volume • 100 µL
Analytical Sensitivity • 0,47 AU/mL
Anti Beta 2 Glycoprotein 1 IgGQuantitative determination of IgG class antibodies against β2-Glicoprotein 1 in human serum or plasma
Sample Type • Serum, Plasma
DKO 110
96 Test
CESample Volume • 100 µL
Analytical sensitivity • 0.47 AU/mL
18 19
Autoimmunity: RheumatologyProduct
CodeProduct Description Size Certification
ANA ScreenSemi-quantitative determination of IgG class against Nuclear Antigens in human serum or plasma
Sample Type • Serum, plasma
DKO 099
96 Test
CESample Volume • 100 µL
Analytical sensitivity • 0.69 AU/mL
Anti CCPQuantitative determination of IgG antibodies against cyclical citrullinated peptides (CCP) in human serum or plasma
Sample Type • Serum, Plasma
DKO 117
96 Test
CESample Volume • 100 µL
Analytical sensitivity • 1.12 U/mL
ENA ProfileIndirect immunoenzymatic determination of IgG class autoantibodies against ENA (Extractable Nuclear Antigens) in human serum
or plasma
Sample Type • Serum, Plasma
DKO 119
96 Test
CESample Volume • 100 µL
Analytical sensitivity • determined for each antigen separately
Anti CP IgGQuantitative determination of IgG class antibodies against Citrullinated Peptides (CP) in human serum or plasma
Sample Type • Serum, Plasma
DKO 149
96 Test
CESample Volume • 100 µL
Analytical sensitivity • 0.16 AU/mL
Autoimmunity: RheumatologyProduct
CodeProduct Description Size Certification
Anti ds-DNA IgGQuantitative determination of IgG class antibodies against ds-DNA in human serum or plasma
Sample Type • Serum, Plasma
DKO 095
96Test
CESample Volume • 100 µL
Analytical sensitivity • 0.135 IU/mL
ENA ScreenQuantitative determination of IgG class antibodies against Extractable Nuclear Antigens (ENA) in human serum or plasma
Sample Type • Serum, Plasma
DKO 098
96Test
CESample Volume • 100 µL
Analytical sensitivity • 3.68 AU/mL
Autoimmunity: Anca VasculitisProduct
CodeProduct Description Size Certification
Anti PR-3 (c-ANCA)Quantitative determination of IgG class antibodies against Proteinase 3 (PR-3) in human serum or plasma.
Sample Type • Serum, Plasma
DKO 091
96Test
CESample Volume • 100 µL
Analytical sensitivity • 0.13 AU/mL
Anti MPO (p-ANCA)Quantitative determination of IgG class antibodies against Myeloperoxidase (MPO) in human serum or plasma
Sample Type • Serum, Plasma
DKO 092
96Test
CESample Volume • 100 µL
Analytical sensitivity • 0.73 AU/mL
KEY: CE = CE Marked RUO = Research Use Only
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Version 1.0 | All rights reserved | © 2015 Immunodiagnostic Systems
www.diametra.com
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IAGNOSTIC SYSTEMS LTD
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Tel: +39 (0) 02 2139184Fax: +39 (0) 02 2133354
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Tel: +44 (0) 191 519 0660Fax: +44 (0) 191 519 0760
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