Department: Testing Laboratory-Medical
Name and Address:
Laboratory name
Address
Phone
Fax
E-Mail
ISO 15189:2007
Accreditation No.
0273
Mogen body Ltd.
Kiryat Mada St. No. 6B , Har Hozvim, Jerusalem 38454
Israel
+972-2-5611958
+972-2-5611959
dvoraha@cc.huji.ac.il
The certificate attached is an integral part of the schedule and is numbered identically ‫התעודה המצורפת לנספח זה מהווה חלק בלתי נפרד ממנו ומספרה זהה למספר הנספח‬
Date of issue
21.12.2014
Version No. 2
Page No.
1
of:
3
Appendix to certificate No.
0273-02
Department
Testing Laboratory-Medical
ISO 15189:2007
Accreditation No.
0273
Appendix to certificate No.
0273-02
Schedule of Accreditation
Item Scope
Type
Site
Types of Test / Properties Measured
Materials / Samples Tested
Test principle / Characteristics
Equipment used / Work station
Opinion and
Interpretation
‫ נוזלי גוף ורקמות מגוף האדם‬:‫ נוזלי גוף ורקמות מגוף האדם משפחת מוצרים‬:‫משפחת מוצרים‬
Group of products: Human Body fluids and Tissues
Medicine – Genetics diagnosis, Screening testing, Confirmation and
characterization Hereditary disease
PCR-based Molecular methods
‫ אישור ואפיון למחלות תורשתיות‬,‫ בדיקות סריקה‬,‫רפואה – גנטיקה‬
PCR ‫שיטות מולקולריות מבוססות‬
kits: Invisiorb, MagNA Pure96,
Qiagen
---
DNA ASP
(Allele Specific PCR)
PCR cycler Electrophoresis
running tank Imaging system
---
DNA
DNA ASP
(Allele Specific PCR)
PCR cycler Electrophoresis
running tank Imaging system
---
Cystic Fibrosis
DNA
DNA ASP
(Allele Specific PCR)
PCR cycler Electrophoresis
running tank Imaging system
---
Familial
Dysautonomia
Familial
Dysautonomia
DNA
DNA ASP
(Allele Specific PCR)
PCR cycler Electrophoresis
running tank Imaging system
---
P
Fanconi anemia C
Fanconi anemia C
DNA
DNA ASP
(Allele Specific PCR)
PCR cycler Electrophoresis
running tank Imaging system
---
A
P
Gaucher disease
Gaucher disease
DNA
DNA ASP
(Allele Specific PCR)
PCR cycler Electrophoresis
running tank Imaging system
---
8
A
P
Glycogen storage
disease AI
Glycogen storage
disease AI
DNA
DNA ASP
(Allele Specific PCR)
PCR cycler Electrophoresis
running tank Imaging system
---
9
A
P
ML4 disease
ML4 disease
DNA
DNA ASP
(Allele Specific PCR)
PCR cycler Electrophoresis
running tank Imaging system
---
10 A
P
Nemaline myopathy
Nemaline myopathy
DNA
DNA ASP
(Allele Specific PCR)
PCR cycler Electrophoresis
running tank Imaging system
---
11 A
P
Niemman Pick
disease
Niemman Pick
disease
DNA
DNA ASP
(Allele Specific PCR)
PCR cycler Electrophoresis
running tank Imaging system
---
12 A
P
Tay Sachs disease
Tay Sachs disease
DNA
DNA ASP
(Allele Specific PCR)
PCR cycler Electrophoresis
running tank Imaging system
---
1
A
P
DNA purification
DNA purification
Blood cells
2
A
P
Bloom syndrome
Bloom syndrome
DNA
3
A
P
Canavan disease
Canavan disease
4
A
P
Cystic Fibrosis
5
A
P
6
A
7
Group of products: Human Body fluids and Tissues
Remarks
‫ תאי דם‬DNA purification
‫ נוזלי גוף ורקמות מגוף האדם‬:‫ נוזלי גוף ורקמות מגוף האדם משפחת מוצרים‬:‫משפחת מוצרים‬
Site: P or T or M, P-Permanent, T-Temporary, M-Mobile
Type of Scopes: A- Fixed, C- Flexible scope in analytical tests : Type of matrix, analytes, experimental systems and/or analytical characteristics may be subject to changes, in accordance with the laboratory's
approved and documented procedures. For details, please refer to the list of Accredited Tests, available from the laboratory upon request.
Date of issue
21.12.2014
Version No. 2
Page No.
2
of:
3
The certificate attached is an integral part of the schedule and is numbered identically ‫התעודה המצורפת לנספח זה מהווה חלק בלתי נפרד ממנו ומספרה זהה למספר הנספח‬
Department
Testing Laboratory-Medical
ISO 15189:2007
Accreditation No.
0273
Appendix to certificate No.
0273-02
Schedule of Accreditation
Item Scope
Type
Site
Types of Test / Properties Measured
Materials / Samples Tested
Test principle / Characteristics
Equipment used / Work station
Medicine – Genetics diagnosis, Screening testing, Confirmation and
characterization Hereditary disease
PCR-based Molecular methods
Opinion and
Interpretation
Remarks
‫ אישור ואפיון למחלות תורשתיות‬,‫ בדיקות סריקה‬,‫רפואה – גנטיקה‬
PCR ‫שיטות מולקולריות מבוססות‬
13 A
P
Usher syndrome la
Usher syndrome la
DNA
DNA ASP
(Allele Specific PCR)
PCR cycler Electrophoresis
running tank Imaging system
---
14 A
P
Non syndromic
hearing loss (GJB2,
GJB6, LOXHD1)
Non syndromic
hearing loss (GJB2,
GJB6, LOXHD1)
DNA
DNA ASP
(Allele Specific PCR)
PCR cycler Electrophoresis
running tank Imaging system
---
15 A
P
Maple syrup Urine
Disease
Maple syrup Urine
Disease
DNA
DNA ASP
(Allele Specific PCR)
PCR cycler Electrophoresis
running tank Imaging system
---
16 A
P
Lipoamide
dehydrogenase
Deficinency
Lipoamide
dehydrogenase
Deficinency
DNA
DNA ASP
(Allele Specific PCR)
PCR cycler Electrophoresis
running tank Imaging system
---
17 A
P
Hyperinsulinemia
Hyperinsulinemia
DNA
DNA ASP
(Allele Specific PCR)
PCR cycler Electrophoresis
running tank Imaging system
---
18 A
P
Joubert syndrome2
Joubert syndrome2
DNA
DNA ASP
(Allele Specific PCR)
PCR cycler Electrophoresis
running tank Imaging system
---
19 A
P
Walker-Warbourg
syndrome
Walker-Warbourg
syndrome
DNA
DNA ASP
(Allele Specific PCR)
PCR cycler Electrophoresis
running tank Imaging system
---
20 A
P
Bardet-Biedl type 2
syndrome
Bardet-Biedl type 2
syndrome
DNA
DNA ASP
(Allele Specific PCR)
PCR cycler Electrophoresis
running tank Imaging system
---
Site: P or T or M, P-Permanent, T-Temporary, M-Mobile
Type of Scopes: A- Fixed, C- Flexible scope in analytical tests : Type of matrix, analytes, experimental systems and/or analytical characteristics may be subject to changes, in accordance with the laboratory's
approved and documented procedures. For details, please refer to the list of Accredited Tests, available from the laboratory upon request.
Date of issue
21.12.2014
Version No. 2
Page No.
3
of:
3
The certificate attached is an integral part of the schedule and is numbered identically ‫התעודה המצורפת לנספח זה מהווה חלק בלתי נפרד ממנו ומספרה זהה למספר הנספח‬