Department: Testing Laboratory-Medical
Name and Address:
Laboratory name
Address
Phone
Fax
E-Mail
Item Scope
Type
Site
Types of Test / Properties Measured
ISO 15189:2012
Accreditation No. 273
Mogen body Ltd.
Kiryat Mada St. No. 6B , Har Hozvim, Jerusalem 45383
Israel
+972-2-5611958
+972-2-5611959
dvoraha@cc.huji.ac.il
Materials / Samples Tested
Test principle / Characteristics
Equipment used / Work station
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
02.04.2015
Version No. 1
Remarks
‫ גנטיקה‬- ‫ רפואה‬,‫ בריאות‬:‫משפחת מוצרים‬
Group of products: Health, Medicine - Genetics
Date of issue
Opinion and
Interpretation
Page No.
1
of:
3
Testing Laboratory-Medical
Department:
Accreditation No. 273
ISO 15189:2012
Schedule of Accreditation
Item Scope
Type
Site
Types of Test / Properties Measured
Materials / Samples Tested
Biological Testing, Screening Testing, Confirmation and Characterization of
Hereditary Diseases, Manual Biochemical/Immunochemical Assays
PCR-based Molecular methods
Test principle / Characteristics
Equipment used / Work station
Opinion and
Interpretation
, ‫אימונוכימיות ידניות‬/‫ שיטות ביוכימיות‬,‫ אישור ואפיון למחלות תורשתיות‬,‫ בדיקות סריקה‬,‫בדיקות ביולוגיות‬
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
---
C
P
Gaucher disease
Gaucher disease
DNA
DNA ASP
(Allele Specific PCR)
PCR cycler Electrophoresis
running tank Imaging system
---
8
C
P
Glycogen storage
disease AI
Glycogen storage
disease AI
DNA
DNA ASP
(Allele Specific PCR)
PCR cycler Electrophoresis
running tank Imaging system
---
9
C
P
ML4 disease
ML4 disease
DNA
DNA ASP
(Allele Specific PCR)
PCR cycler Electrophoresis
running tank Imaging system
---
10 C
P
Nemaline myopathy
Nemaline myopathy
DNA
DNA ASP
(Allele Specific PCR)
PCR cycler Electrophoresis
running tank Imaging system
---
11 C
P
Niemman Pick
disease
Niemman Pick
disease
DNA
DNA ASP
(Allele Specific PCR)
PCR cycler Electrophoresis
running tank Imaging system
---
12 C
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
C
P
cBloom syndrome
Bloom syndrome
DNA
3
C
P
Canavan disease
Canavan disease
4
C
P
Cystic Fibrosis
5
C
P
6
C
7
Remarks
‫ תאי דם‬DNA purification
---
‫ גנטיקה‬- ‫ רפואה‬,‫ בריאות‬:‫משפחת מוצרים‬
Group of products: Health, Medicine - Genetics
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
02.04.2015
Version No. 1
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
Testing Laboratory-Medical
Department:
Accreditation No. 273
ISO 15189:2012
Schedule of Accreditation
Item Scope
Type
Site
Types of Test / Properties Measured
Materials / Samples Tested
Biological Testing, Screening Testing, Confirmation and Characterization of
Hereditary Diseases, Manual Biochemical/Immunochemical Assays
PCR-based Molecular methods
Test principle / Characteristics
Equipment used / Work station
Opinion and
Interpretation
Remarks
, ‫אימונוכימיות ידניות‬/‫ שיטות ביוכימיות‬,‫ אישור ואפיון למחלות תורשתיות‬,‫ בדיקות סריקה‬,‫בדיקות ביולוגיות‬
PCR ‫שיטות מולקולריות מבוססות‬
13 C
P
Usher syndrome la
Usher syndrome la
DNA
DNA ASP
(Allele Specific PCR)
PCR cycler Electrophoresis
running tank Imaging system
---
14 C
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 C
P
Maple syrup Urine
Disease
Maple syrup Urine
Disease
DNA
DNA ASP
(Allele Specific PCR)
PCR cycler Electrophoresis
running tank Imaging system
---
16 C
P
Lipoamide
dehydrogenase
Deficinency
Lipoamide
dehydrogenase
Deficinency
DNA
DNA ASP
(Allele Specific PCR)
PCR cycler Electrophoresis
running tank Imaging system
---
17 C
P
Hyperinsulinemia
Hyperinsulinemia
DNA
DNA ASP
(Allele Specific PCR)
PCR cycler Electrophoresis
running tank Imaging system
---
18 C
P
Joubert syndrome2
Joubert syndrome2
DNA
DNA ASP
(Allele Specific PCR)
PCR cycler Electrophoresis
running tank Imaging system
---
19 C
P
Walker-Warbourg
syndrome
Walker-Warbourg
syndrome
DNA
DNA ASP
(Allele Specific PCR)
PCR cycler Electrophoresis
running tank Imaging system
---
20 C
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
02.04.2015
Version No. 1
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