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0325 Accreditation No. ISO 15189 :2012 Testing Laboratory-Medical Department: Date of issue 07.06.2016 Version No. 1 Page No. 1 of: 12 התעודה המצורפת לנספח זה מהווה חלק בלתי נפרד ממנו ומספרה זהה למספר הנספחThe certificate attached is an integral part of the schedule and is numbered identically This appendix includes 3 parts, one for each accredited organization in the list below: Name and Address: Division of Laboratories Hadassah Medical Organization Kiryat Hadassah,The Hadassah medical center P.O.Box 12000, Jerusalem 91120 Israel Organization name Address +972-2-677-6841, +972-2-677-6213 Phone +972-2-643-5778 Fax [email protected] E-Mail (contact person) 1. Pharmacology, Immunology and Clinical Allergy Division 2. Hematology Division 3. Clinical Biochemistry Division
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  • 0325 Accreditation No. ISO 15189 :2012 Testing Laboratory-Medical Department:

    Date of issue 07.06.2016 Version No. 1 Page No. 1 of: 12

    The certificate attached is an integral part of the schedule and is numbered identicallyהתעודה המצורפת לנספח זה מהווה חלק בלתי נפרד ממנו ומספרה זהה למספר הנספח

    This appendix includes 3 parts, one for each accredited organization in the list below:

    Name and Address:

    Division of Laboratories Hadassah Medical Organization

    Kiryat Hadassah,The Hadassah medical center

    P.O.Box 12000, Jerusalem 91120 Israel

    Organization name

    Address

    +972-2-677-6841, +972-2-677-6213 Phone

    +972-2-643-5778 Fax

    [email protected]

    E-Mail (contact person)

    1. Pharmacology, Immunology and Clinical Allergy Division

    2. Hematology Division

    3. Clinical Biochemistry Division

    mailto:[email protected]

  • 0325 Accreditation No. ISO 15189 :2012 Testing Laboratory-Medical Department:

    Schedule of Accreditation

    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 07.06.2016 Version No. 1 Page No. 2 of: 12 The certificate attached is an integral part of the schedule and is numbered identicallyנספח התעודה המצורפת לנספח זה מהווה חלק בלתי נפרד ממנו ומספרה זהה למספר ה

    Name and Address: Division of Laboratories Hadassah Medical Organization

    Pharmacology, Immunology and Clinical Allergy

    Organization name

    Division Kiryat Hadassah,The Hadassah medical center

    P.O.Box 12000, Jerusalem 91120 Israel

    Address

    +972-2-6776841 Phone +972-2-6776270 Fax [email protected] E-Mail

  • 0325 Accreditation No. ISO 15189 :2012 Testing Laboratory-Medical Department:

    Schedule of Accreditation

    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 07.06.2016 Version No. 1 Page No. 3 of: 12 The certificate attached is an integral part of the schedule and is numbered identicallyנספח התעודה המצורפת לנספח זה מהווה חלק בלתי נפרד ממנו ומספרה זהה למספר ה

    Ite

    m

    Scope

    Type

    Site Types of Test / Properties Measured Materials / Samples Tested Test principle / Characteristics Equipment used / Work station Opinion and

    Interpretation

    Remarks

    Group of products: Health, Medicine - Immunology & Pharmacology :ופרמקולוגיהאימונולוגיה -בריאות, רפואה משפחת מוצרים

    Biological Testing, Autoanalysers ,שיטות באוטואנלייזרים בדיקות ביולוגיות

    1 A P C3 C3 Serum/ Plasma סרום, פלזמה Immunoturbidimetric Cobas 6000

    ---

    2 A P C4 C4 Serum/ Plasma סרום, פלזמה Immunoturbidimetric Cobas 6000

    ---

    3 A P Cyclosporin Cyclosporin Whole blood דם מלא Chemiluminescent

    Architect

    ---

    4 A P IgA IgA Serum/ Plasma סרום, פלזמה

    Immunoturbidimetric Cobas 6000 ---

    5 A P IgG IgG Serum/ Plasma סרום, פלזמה Immunoturbidimetric Cobas 6000

    ---

    6 A P IgM IgM Serum/ Plasma סרום, פלזמה Immunoturbidimetric Cobas 6000

    ---

    7 A P Sirolimus Sirolimus Whole blood דם מלא Chemiluminescent

    Architect

    ---

    8 A P Tacrolimus FK Tacrolimus FK Whole blood דם מלא Chemiluminescent

    Architect

    ---

  • 0325 Accreditation No. ISO 15189 :2012 Testing Laboratory-Medical Department:

    Schedule of Accreditation

    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 07.06.2016 Version No. 1 Page No. 4 of: 12 The certificate attached is an integral part of the schedule and is numbered identicallyנספח התעודה המצורפת לנספח זה מהווה חלק בלתי נפרד ממנו ומספרה זהה למספר ה

    Name and Address: Division of Laboratories Hadassah Medical Organization

    Hematology

    Organization name

    Division Kiryat Hadassah,The Hadassah medical center

    P.O.Box 12000, Jerusalem 91120 Israel

    Address

    +972-2-6776761 Phone +972-2-6776270 Fax [email protected] E-Mail

  • 0325 Accreditation No. ISO 15189 :2012 Testing Laboratory-Medical Department:

    Schedule of Accreditation

    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 07.06.2016 Version No. 1 Page No. 5 of: 12 The certificate attached is an integral part of the schedule and is numbered identicallyנספח התעודה המצורפת לנספח זה מהווה חלק בלתי נפרד ממנו ומספרה זהה למספר ה

    Item Scope

    Type

    Site Types of Test / Properties Measured Materials / Samples Tested Test principle / Characteristics Equipment used /

    Work station

    Opinion and

    Interpretation

    Remarks

    Group of products: Health, Medicine - Hematology, Blood Count :המטולוגיה, ספירה -בריאות, רפואה משפחת מוצרים

    Biological Testing, Blood Count by Autoanalysers ספירה באוטואנלייזרים, בדיקות ביולוגיות

    9 A P CBC (Complete Blood Count)

    Whole blood ספירת דם כללית

    (K2EDTA)

    EDTA)2(K Automated cell counterדם מלא LH instruments

    --- Including all parameter listed

    below

    10 A P Basophils Basophils Whole blood (KEDTA)

    EDTA)2(K Automated cell counterדם מלא LH instruments

    ---

    11 A P Blasts Blasts Whole blood (K2EDTA)

    EDTA)2(K Automated cell counterדם מלא LH instruments

    ---

    12 A P Eosinophils Eosinophils Whole blood (K2EDTA)

    EDTA)2(K Automated cell counterדם מלא LH instruments

    ---

    13 A P Hematocrit Hematocrit Whole blood (K2EDTA)

    EDTA)2(K Automated cell counterדם מלא LH instruments

    ---

    14 A P Hemoglobin המוגלובין Whole blood (K2EDTA)

    EDTA)2(K Automated cell counterדם מלא LH instruments

    ---

    15 A P Hypercytosis Hypercytosis Whole blood (K2EDTA)

    EDTA)2(K Automated cell counterדם מלא LH instruments

    ---

    16 A P Hypocytosis Hypocytosis Whole blood (K2EDTA)

    EDTA)2(K Automated cell counterדם מלא LH instruments

    ---

    17 A P Left shift Left shift Whole blood (K2EDTA)

    EDTA)2(K Automated cell counterדם מלא LH instruments

    ---

    18 A P Lymphocytes Lymphocytes Whole blood (K2EDTA)

    EDTA)2(K Automated cell counterדם מלא LH instruments

    ---

    19 A P Macrocytes Macrocytes Whole blood (K2EDTA)

    EDTA)2(K Automated cell counterדם מלא LH instruments

    ---

    20 A P MCH (Mean Cell Hemoglobin)

    MCH (Mean Cell

    Hemoglobin)

    Whole blood

    (K2EDTA)

    EDTA)2(K Automated cell counterדם מלא LH instruments

    ---

    21 A P MCHC (Mean Cell Hemoglobin

    Concentration)

    MCHC (Mean Cell

    Hemoglobin

    Concentration)

    Whole blood

    (K2EDTA)

    EDTA)2(K Automated cell counterדם מלא LH instruments

    ---

  • 0325 Accreditation No. ISO 15189 :2012 Testing Laboratory-Medical Department:

    Schedule of Accreditation

    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 07.06.2016 Version No. 1 Page No. 6 of: 12 The certificate attached is an integral part of the schedule and is numbered identicallyנספח התעודה המצורפת לנספח זה מהווה חלק בלתי נפרד ממנו ומספרה זהה למספר ה

    Item Scope

    Type

    Site Types of Test / Properties Measured Materials / Samples Tested Test principle / Characteristics Equipment used / Work station

    Opinion and Interpretation

    Remarks

    Group of products: Health, Medicine - Hematology, Blood Count :המטולוגיה, ספירה -בריאות, רפואה משפחת מוצרים

    Biological Testing, Blood Count by Autoanalysers ספירה באוטואנלייזרים, בדיקות ביולוגיות

    22 A P MCV (Mean Cell Volume)

    MCV (Mean Cell

    Volume)

    Whole blood

    (K2EDTA)

    EDTA)2(K Automated cell counterדם מלא LH instruments

    ---

    23 A P Microcytes Microcytes Whole blood (K2EDTA)

    EDTA)2(K Automated cell counterדם מלא LH instruments

    ---

    24 A P Monocytes Monocytes Whole blood (K2EDTA)

    EDTA)2(K Automated cell counterדם מלא LH instruments

    ---

    25 A P MPV (Mean Platelet Volume)

    MPV (Mean Platelet

    Volume)

    Whole blood

    (K2EDTA)

    EDTA)2(K Automated cell counterדם מלא LH instruments

    ---

    26 A P Neutrophils (Polymorphonuclears)

    Neutrophils

    (Polymorphonuclears)

    Whole blood

    (K2EDTA)

    EDTA)2(K Automated cell counterדם מלא LH instruments

    ---

    27 A P PCT (Platelets Hematocrit)

    PCT (Platelets

    Hematocrit)

    Whole blood

    (K2EDTA)

    EDTA)2(K Automated cell counterדם מלא LH instruments

    ---

    28 A P PLT (Platelets) PLT (Platelets) Whole blood (K2EDTA)

    EDTA)2(K Automated cell counterדם מלא LH instruments

    ---

    29 A P RBC (Red Blood Cells)

    Whole blood תאי דם אדומים

    (K2EDTA)

    EDTA)2(K Automated cell counterדם מלא LH instruments

    ---

    30 A P RDW (Red Blood Cell Distribution Width)

    RDW (Red Blood Cell

    Distribution Width)

    Whole blood

    (K2EDTA)

    EDTA)2(K Automated cell counter LH instrumentsדם מלא ---

    31 A P WBC (White Blood Cells)

    Whole blood תאי דם לבנים

    (K2EDTA)

    EDTA)2(K Automated cell counter LH instrumentsדם מלא ---

    32 A P RETIC (Reticulocyte) תאי דם צעירים Whole blood (K2EDTA

    EDTA)2(K Automated cell counter LH instrumentsדם מלא ---

  • 0325 Accreditation No. ISO 15189 :2012 Testing Laboratory-Medical Department:

    Schedule of Accreditation

    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 07.06.2016 Version No. 1 Page No. 7 of: 12 The certificate attached is an integral part of the schedule and is numbered identicallyנספח התעודה המצורפת לנספח זה מהווה חלק בלתי נפרד ממנו ומספרה זהה למספר ה

    Item Scope

    Type

    Site Types of Test / Properties Measured Materials / Samples Tested Test principle / Characteristics Equipment used /

    Work station

    Opinion and

    Interpretation

    Remarks

    Group of products: Health, Medicine - Hematology המטולוגיה -משפחת מוצרים: בריאות, רפואה

    Biological Testing, Blood Cell Typing Manual smear בדיקות ביולוגיות, אפיון תאי דם, משטח ידני

    33 A P Blood Smears or Films:

    Normal blood films

    Young cells: Stabs, MetaMyelocytes,

    Myelocytes,

    Promyrlocytes, Blasts. Atypical

    Lymphocytes.,

    Monocytes, Granulocytes

    Red Blood Cell

    pathology. Leukemic blood

    smears.

    Abnormalities in Platelets.

    Blood Smears or Films:

    Normal blood films

    Young cells: Stabs,

    MetaMyelocytes, Myelocytes,

    Promyrlocytes, Blasts.

    Atypical Lymphocytes., Monocytes,

    Granulocytes

    Red Blood Cell pathology.

    Leukemic blood smears.

    Abnormalities in Platelets.

    Whole blood דם מלא Microscopy on Gimsa stained

    slides.

    Hematek

    ---

    Item Scope

    Type

    Site Types of Test / Properties Measured Materials / Samples Tested Test principle / Characteristics Equipment used / Work station

    Opinion and Interpretation

    Remarks

    Group of products: Health, Medicine - Hematology, Coagulation המטולוגיה, קרישה -משפחת מוצרים: בריאות, רפואה

    Biological Testing, Autoanalysers בדיקות ביולוגיות, שיטות באוטואנלייזרים

    34 A P Factor VIII Factor VIII Plasma, (Na Citrate)

    Na Citrate)) Clot detection photometryלסמה פ

    Factor VIII DP: IL

    PTT Synthasil IL

    ACL Top 500

    ---

  • 0325 Accreditation No. ISO 15189 :2012 Testing Laboratory-Medical Department:

    Schedule of Accreditation

    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 07.06.2016 Version No. 1 Page No. 8 of: 12 The certificate attached is an integral part of the schedule and is numbered identicallyנספח התעודה המצורפת לנספח זה מהווה חלק בלתי נפרד ממנו ומספרה זהה למספר ה

    Name and Address: Division of Laboratories Hadassah Medical Organization

    Clinical Biochemistry

    Organization name

    Division Kiryat Hadassah,The Hadassah medical center

    P.O.Box 12000, Jerusalem 91120 Israel

    Address

    +972-2-6776841 Phone +972-2-6776270 Fax [email protected] E-Mail

  • 0325 Accreditation No. ISO 15189 :2012 Testing Laboratory-Medical Department:

    Schedule of Accreditation

    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 07.06.2016 Version No. 1 Page No. 9 of: 12 The certificate attached is an integral part of the schedule and is numbered identicallyנספח התעודה המצורפת לנספח זה מהווה חלק בלתי נפרד ממנו ומספרה זהה למספר ה

    Item Scope

    Type

    Site Types of Test / Properties Measured Materials / Samples Tested Test principle / Characteristics Equipment used /

    Work station

    Opinion and

    Interpretation

    Remarks

    Group of products: Health, Medicine - Chemistry, General Biochemistry :כימיה, ביוכימיה כללית -בריאות, רפואה משפחת מוצרים

    Chemical Testing, Autoanalysers בדיקות כימיות, שיטות באוטואנלייזרים

    35 A P Albumin אלבומין Serum סרום Chemistry analyser Cobas 6000 ---

    36 A P Albumin אלבומין Urine שתן Immunoturbido-metric Cobas 6000 ---

    37 A P Alcohol) (Ethanol)

    אלכוהול

    )אתנול(

    Serum סרום Chemistry analyser Cobas 6000 ---

    38 A P Alkaline Phosphatase Alkaline Phosphatase Serum סרום Chemistry analyser Cobas 6000 ---

    39 A P Ammonia אמוניה Serum סרום Chemistry analyser Cobas 6000 ---

    40 A P Amylase עמילאז Serum, Urine שתןסרום , Chemistry analyser Cobas 6000 ---

    41 A P Bilirubin (Direct) )בילירובין )ישיר Serum סרום Chemistry analyser Cobas 6000 ---

    42 A P Bilirubin (Total) )בילירובין )כללי Serum סרום Chemistry analyser Cobas 6000 ---

    43 A P Calcium סידן Serum, Urine שתןסרום , Chemistry analyser Cobas 6000 ---

    44 A P Chloride כלוריד Serum סרום Chemistry analyser Cobas 6000 ---

    45 A P Cholesterol כולסטרול Serum סרום Chemistry analyser Cobas 6000 ---

    46 A P C-Reactive Protein C-Reactive Protein Serum סרום Immunoturbido-metric Cobas 6000 ---

    47 A P Creatine Kinase (CK) Creatine Kinase (CK) Serum סרום Chemistry analyser Cobas 6000 ---

  • 0325 Accreditation No. ISO 15189 :2012 Testing Laboratory-Medical Department:

    Schedule of Accreditation

    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 07.06.2016 Version No. 1 Page No. 10 of: 12 The certificate attached is an integral part of the schedule and is numbered identicallyנספח התעודה המצורפת לנספח זה מהווה חלק בלתי נפרד ממנו ומספרה זהה למספר ה

    Item Scope

    Type

    Site Types of Test / Properties Measured Materials / Samples Tested Test principle / Characteristics Equipment used / Work station

    Opinion and Interpretation

    Remarks

    Group of products: Health, Medicine - Chemistry, General Biochemistry :יה, ביוכימיה כלליתכימ -בריאות, רפואה משפחת מוצרים

    Chemical Testing, Autoanalysers בדיקות כימיות, שיטות באוטואנלייזרים

    48 A P Creatinine Creatinine Serum סרום Chemistry analyser Cobas 6000 ---

    49 A P Diastase דיאסטאז Serum, Urine שתןסרום , Chemistry analyser Cobas 6000 ---

    50 A P GGT (Gama(γ)-glutamyl transpeptidase)

    GGT (Gama(γ)-glutamyl

    transpeptidase)

    Serum סרום Chemistry analyser Cobas 6000 ---

    51 A P Glucose גלוקוז Serum, Urine, Pleural Fluid, CSF

    , שתן, נוזל עמוד שדרה, סרום

    נוזל צדר

    Chemistry analyser Cobas 6000 --- CSF – Cerebro spinal fluid

    52 A P GTT (Glucose Tolerance Test)

    GTT (Glucose Tolerance

    Test)

    Serum סרום Chemistry analyser Cobas 6000 ---

    53 A P HDL (High Density Lipoprotein) cholesterol

    HDL (High Density

    Lipoprotein) cholesterol

    Serum סרום Immunochemistry Cobas 6000 ---

    54 A P Iron ברזל Serum סרום Immunochemistry Cobas 6000 ---

    55 A P Lactate, (Lactic Acid) חומצה לקטית Serum, CSF נוזל צדרסרום , Chemistry analyser Cobas 6000 ---

    56 A P LDH (Lactate Dehydrogenase)

    LDH (Lactate

    Dehydrogenase)

    Serum, Pleural Fluid נוזל עמוד שדרהסרום , Chemistry analyser Cobas 6000 ---

    57 A P Lithium ליתיום Serum סרום Chemistry analyser Cobas 6000 ---

    58 A P Magnesium מגנזיום Serum, Urine שתןסרום , Chemistry analyser Cobas 6000 ---

    59 A P Microalbumin מיקרואלבומין Urine שתן Immunoturbido-metric Cobas 6000 ---

    60 A P Phosphorus Phosphorus Serum, Urine שתןסרום , Chemistry analyser Cobas 6000 ---

  • 0325 Accreditation No. ISO 15189 :2012 Testing Laboratory-Medical Department:

    Schedule of Accreditation

    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 07.06.2016 Version No. 1 Page No. 11 of: 12 The certificate attached is an integral part of the schedule and is numbered identicallyנספח התעודה המצורפת לנספח זה מהווה חלק בלתי נפרד ממנו ומספרה זהה למספר ה

    Item Scope

    Type

    Site Types of Test / Properties Measured Materials / Samples Tested Test principle / Characteristics Equipment used / Work station

    Opinion and Interpretation

    Remarks

    Group of products: Health, Medicine - Chemistry, General Biochemistry :כימיה, ביוכימיה כללית -בריאות, רפואה משפחת מוצרים

    Chemical Testing, Autoanalysers בדיקות כימיות, שיטות באוטואנלייזרים

    61 A P Potassium אשלגן Serum, Urine שתןסרום , Chemistry analyser Cobas 6000 ---

    62 A P Protein חלבון Urine שתן Chemistry analyser Cobas 6000 ---

    63 A P Protein (Total) )חלבון )כלל Serum, Pleural Fluid, CSF

    , נוזל עמוד שדרה, נוזל סרום

    צדר

    Chemistry analyser Cobas 6000 ---

    64 A P Protein Creatinine Ratio

    Protein Creatinine Ratio Urine שתן Calculation Cobas 6000 ---

    65 A P SGOT (Serum Glutamic Oxaloacetic

    Transaminase) AST (Aspartate

    aminotransferase)

    SGOT (Serum Glutamic

    Oxaloacetic

    Transaminase) AST (Aspartate

    aminotransferase)

    Serum סרום Chemistry analyser Cobas 6000

    ---

    66 A P SGPT (Serum Glutamic Pyruvic

    Transaminase)

    ALT (Alanine aminotransferase)

    SGPT (Serum Glutamic

    Pyruvic Transaminase)

    ALT (Alanine

    aminotransferase)

    Serum סרום Chemistry analyser Cobas 6000

    ---

    67 A P Sodium נתרן Serum, Urine שתןסרום , Chemistry analyser Cobas 6000 ---

    68 A P TIBC (Total Iron Binding Capacity)

    TIBC (Total Iron

    Binding Capacity) Plasma פלזמה Calculation Cobas 6000

    ---

    69 A P Transferrin Transferrin Serum סרום Immunoturbido-metric Cobas 6000 ---

  • 0325 Accreditation No. ISO 15189 :2012 Testing Laboratory-Medical Department:

    Schedule of Accreditation

    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 07.06.2016 Version No. 1 Page No. 12 of: 12 The certificate attached is an integral part of the schedule and is numbered identicallyנספח התעודה המצורפת לנספח זה מהווה חלק בלתי נפרד ממנו ומספרה זהה למספר ה

    Item Scope

    Type

    Site Types of Test / Properties Measured Materials / Samples Tested Test principle / Characteristics Equipment used / Work station

    Opinion and Interpretation

    Remarks

    Group of products: Health, Medicine - Chemistry, General Biochemistry :כימיה, ביוכימיה כללית -בריאות, רפואה משפחת מוצרים

    Chemical Testing, Autoanalysers בדיקות כימיות, שיטות באוטואנלייזרים

    70 A P Triglycerides טריגליצרידים Serum סרום Chemistry analyser Cobas 6000 ---

    71 A P Urea Urea Serum, Urine שתןסרום , Chemistry analyser Cobas 6000 ---

    72 A P Uric Acid Uric Acid Serum, Urine שתןסרום , Chemistry analyser Cobas 6000 ---

    73 A P Uric Acid Clearance Uric Acid Clearance Serum, Urine שתןסרום , Calculation ---

    Item Scope

    Type

    Site Types of Test / Properties Measured Materials / Samples Tested Test principle /

    Characteristics

    Equipment used /

    Work station

    Opinion and

    Interpretation

    Remarks

    Group of products: Health, Medicine - Chemistry, General Biochemistry,

    Hemodynamics and Oxymetry

    כימיה, ביוכימיה כללית, המודינמיקה ואוקסימטריה -משפחת מוצרים: בריאות, רפואה

    Chemical Testing, Autoanalysers בדיקות כימיות, שיטות באוטואנלייזרים

    74 A P (PCO2) Carbon dioxide, Partial

    Pressure

    (PCO2) Carbon dioxide,

    Partial Pressure

    Whole blood (Na

    Heparin)

    Na Heparin) Blood gas OMNI S)דם מלא

    ---

    75 A P (PO2) Oxygen, Partial Pressure

    (PO2) Oxygen, Partial

    Pressure

    Whole blood (Na

    Heparin)

    Na Heparin) Blood gas OMNI S)דם מלא ---

    76 A P CO.Hb (Carboxyhemoglobin)

    CO.Hb

    (Carboxyhemoglobin)

    Whole blood (Na

    Heparin)

    Na Heparin) Blood gas OMNI S)דם מלא ---

    77 A P pH pH Whole blood (Na Heparin)

    Na Heparin) Blood gas OMNI S)דם מלא ---


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