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9900-05 Appendix to certificate No. 9900 Accreditation No. ISO 15189 Testing Laboratory-Medical Department:
.
Date of issue 09.03.2014 Version No. 2 Page No. 1 of: 17
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
Name and Address:
American Medical Laboratories (Israel) Ltd.
Herzliya Medical Center
37, Havatzelet Hasharon, Herzliya Pituach, 46641, Israel
Laboratory name
Address
+972-9-956-8634 Phone
+972-9-956-8128 Fax [email protected] E-Mail (contact person)
9900-05 Appendix to certificate No. 9900 Accreditation No. ISO 15189 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 09.03.2014 Version No. 2 Page No. 2 of: 17
The certificate attached is an integral part of the schedule and is numbered identicallyצורפת לנספח זה מהווה חלק בלתי נפרד ממנו ומספרה זהה למספר הנספח התעודה המ
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
Biological Testing, Manual Immunoassays בדיקות ביולוגיות, שיטות אימונוכימיות ידניות
1 A P Bilirubin בילירובין Urine שתן Dipstick Miditron Junior
Miditron M ---
2 A P Glucose גלוקוז Urine שתן Dipstick Miditron Junior
Miditron M ---
3 A P Ketones Ketones Urine שתן Dipstick Miditron Junior
Miditron M ---
4 A P Nitrites Nitrites Urine שתן Dipstick Miditron Junior
Miditron M ---
5 A P pH pH Urine שתן Dipstick Miditron Junior
Miditron M ---
6 A P Protein חלבון Urine שתן Dipstick Miditron Junior
Miditron M ---
7 A P RBC (Red Blood Cells) תאי דם אדומים Urine שתן Dipstick Miditron Junior
Miditron M ---
8 A P Specific gravity משקל סגולי Urine שתן Dipstick Miditron Junior
Miditron M ---
9 A P Urobilinogen Urobilinogen Urine שתן Dipstick Miditron Junior
Miditron M ---
10 A P WBC (White Blood
Cells)
Dipstick Miditron Junior שתן Urine תאי דם לבנים
Miditron M ---
11 A P Albumin אלבומין Serum סרום Spectrophotometric Cobas 6000 c501 ---
9900-05 Appendix to certificate No. 9900 Accreditation No. ISO 15189 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 09.03.2014 Version No. 2 Page No. 3 of: 17
The certificate attached is an integral part of the schedule and is numbered identicallyצורפת לנספח זה מהווה חלק בלתי נפרד ממנו ומספרה זהה למספר הנספח התעודה המ
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
Biological Testing, Manual Immunoassays בדיקות ביולוגיות, שיטות אימונוכימיות ידניות
12 A P Albumin אלבומין Urine שתן Immunoturbidimetric Cobas 6000 c501 ---
13 A P Albumin/ Creatinine ratio יחסAlbumin/ Creatinine Urine שתן calculation Cobas 6000 c501 ---
14 A P Albumin/Globulin Albumin/Globulin Serum סרום calculation Cobas 6000 c501 ---
15 A P Alkaline Phosphatase Alkaline Phosphatase Serum סרום Rate reaction Cobas 6000 c501 ---
16 A P Amylase Amylase Serum סרום Rate reaction Cobas 6000 c501 ---
17 A P Bilirubin (Direct) Bilirubin (Direct) Serum סרום Spectrophotometric Cobas 6000 c501 ---
18 A P Bilirubin (Indirect) Bilirubin (Indirect) Serum סרום calculation Cobas 6000 c501 ---
19 A P Bilirubin (Total) )בילירובין )כללי Serum סרום Spectrophotometric Cobas 6000 c501 ---
20 A P BUN (Blood Urea
Nitrogen)
BUN (Blood Urea
Nitrogen)
Serum סרום Enzymatic Cobas 6000 c501 ---
21 A P C3 Complement C3 Complement Serum סרום Immunoturbidimetric Cobas 6000 c501 ---
22 A P C4 Complement C4 Complement Serum סרום Immunoturbidimetric Cobas 6000 c501 ---
9900-05 Appendix to certificate No. 9900 Accreditation No. ISO 15189 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 09.03.2014 Version No. 2 Page No. 4 of: 17
The certificate attached is an integral part of the schedule and is numbered identicallyצורפת לנספח זה מהווה חלק בלתי נפרד ממנו ומספרה זהה למספר הנספח התעודה המ
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 רים:משפחת מוצ
Biological Testing, Manual Immunoassays בדיקות ביולוגיות, שיטות אימונוכימיות ידניות
23 A P Calcium סידן Urine שתן Spectrophotometric Cobas 6000 c501 ---
24 A P Calcium סידן Serum סרום Spectrophotometric Cobas 6000 c501 ---
25 A P Calcium output Calcium output Urine 24 h שעות 42איסוף שתן Calculation Cobas 6000 c501 ---
26 A P Chloride כלוריד Serum סרום Indirect ISE (Ion Selective
Electrode)
Cobas 6000 c501 ---
27 A P Chloride כלוריד Urine שתן Indirect ISE (Ion Selective
Electrode)
Cobas 6000 c501 ---
28 A P Chloride output Urine 24 h שעות 42איסוף שתן Calculation Cobas 6000 c501 ---
29 A P Cholesterol כולסטרול Serum סרום Enzymatic-Colorimetric Cobas 6000 c501 ---
30 A P CO2- Carbon dioxide CO2- Carbon dioxide Serum סרום Enzymatic Cobas 6000 c501 ---
31 A P CPK CPK Serum סרום Rate reaction Cobas 6000 c501 ---
32 A P CPK MB CPK MB Serum סרום Immunoinhibition, kinetic Cobas 6000 c501 ---
33 A P Creatinine Creatinine Serum סרום Spectrophotometric Cobas 6000 c501 ---
9900-05 Appendix to certificate No. 9900 Accreditation No. ISO 15189 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 09.03.2014 Version No. 2 Page No. 5 of: 17
The certificate attached is an integral part of the schedule and is numbered identicallyצורפת לנספח זה מהווה חלק בלתי נפרד ממנו ומספרה זהה למספר הנספח התעודה המ
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
Biological Testing, Manual Immunoassays בדיקות ביולוגיות, שיטות אימונוכימיות ידניות
34 A P Creatinine Creatinine Urine שתן Spectrophotometric Cobas 6000 c501 ---
35 A P Creatinine clearance Creatinine clearance Urine 24 h שעות 42איסוף שתן Calculation Cobas 6000 c501 ---
36 A P Creatinine output Creatinine output Urine 24 h שעות 42איסוף שתן Calculation Cobas 6000 c501 ---
37 A P CRP (C-reactive Protein ) CRP (C-reactive Protein ) Serum סרום Immunoturbidimetric Cobas 6000 c501 ---
38 A P Diastase – amylase Diastase – amylase Urine שתן Rate reaction Cobas 6000 c501 ---
39 A P Gamma Glutamyl
Transpeptidase
Gamma Glutamyl
Transpeptidase Serum סרום Rate reaction Cobas 6000 c501
---
40 A P Globulin Globulin Serum סרום Calculation Cobas 6000 c501 ---
41 A P Glucose גלוקוז Serum סרום Enzymatic, spectrophotometric Cobas 6000 c501 ---
42 A P Haptoglobin Haptoglobin Serum סרום Immunoturbidimetric Cobas 6000 c501 ---
43 A P HDL (Lactate
Dehydrogenase)
cholesterol
HDL (Lactate
Dehydrogenase)
cholesterol
Serum סרום Enzymatic, spectrophotometric Cobas 6000 c501
---
44 A P Hemoglobin A1c Hemoglobin A1c Whole blood דם מלא TINIA (Turbidimetric
Inhibition Immunoassay)
Cobas 6000 c501 ---
9900-05 Appendix to certificate No. 9900 Accreditation No. ISO 15189 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 09.03.2014 Version No. 2 Page No. 6 of: 17
The certificate attached is an integral part of the schedule and is numbered identicallyצורפת לנספח זה מהווה חלק בלתי נפרד ממנו ומספרה זהה למספר הנספח התעודה המ
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
Biological Testing, Manual Immunoassays בדיקות ביולוגיות, שיטות אימונוכימיות ידניות
45 A P IgA IgA Serum סרום Immunoturbidimetric Cobas 6000 c501 ---
46 A P IgG IgG Serum סרום Immunoturbidimetric Cobas 6000 c501 ---
47 A P IgM IgM Serum סרום Immunoturbidimetric Cobas 6000 c501 ---
48 A P Iron ברזל Serum סרום Spectrophotometric Cobas 6000 c501 ---
49 A P LDH LDH Serum סרום Rate reaction Cobas 6000 c501 ---
50 A P LDL cholesterol LDL cholesterol Serum סרום Enzymatic, spectrophotometric Cobas 6000 c501 ---
51 A P Lipase ליפאז Serum סרום Enzymatic spectro-
photometric Rate reaction
Cobas 6000 c501 ---
52 A P Magnesium מגנזיום Serum סרום Spectrophotometric Cobas 6000 c501 ---
53 A P Magnesium מגנזיום Urine שתן Spectrophotometric Cobas 6000 c501 ---
54 A P Magnesium output Magnesium output Urine 24 h שעות 42איסוף שתן calculation Cobas 6000 c501 ---
55 A P Phosphorus Phosphorus Urine שתן Spectrophotometric Cobas 6000 c501 ---
9900-05 Appendix to certificate No. 9900 Accreditation No. ISO 15189 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 09.03.2014 Version No. 2 Page No. 7 of: 17
The certificate attached is an integral part of the schedule and is numbered identicallyצורפת לנספח זה מהווה חלק בלתי נפרד ממנו ומספרה זהה למספר הנספח התעודה המ
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
Biological Testing, Manual Immunoassays יקות ביולוגיות, שיטות אימונוכימיות ידניותבד
56 A P Phosphorus output Phosphorus output Urine 24 h שעות 42איסוף שתן Spectrophotometric Cobas 6000 c501 ---
57 A P Phosphorus Phosphorus Serum סרום Spectrophotometric Cobas 6000 c501 ---
58 A P Potassium אשלגן Serum סרום Indirect ISE (Ion selective
Electrode)
Cobas 6000 c501 ---
59 A P Potassium אשלגן Urine שתן Indirect ISE Cobas 6000 c501 ---
60 A P Potassium output Potassium output Urine 24 h שעות 42איסוף שתן calculation Cobas 6000 c501 ---
61 A P Protein (Total) )חלבון )כללי Serum סרום Spectrophotometric Cobas 6000 c501 ---
62 A P Protein (Total) )חלבון )כללי Urine שתן Spectrophotometric Cobas 6000 c501 ---
63 A P SGOT
AST
SGOT
AST
Serum סרום Enzymatic
spectrophotometric Rate
reaction
Cobas 6000 c501
---
64 A P SGPT
ALT
SGPT
ALT
Serum סרום Enzymatic spectro-
photometric Rate reaction
Cobas 6000 c501 ---
65 A P Sodium נתרן Serum סרום Indirect ISE Cobas 6000 c501 ---
66 A P Sodium נתרן Urine שתן Indirect ISE Cobas 6000 c501 ---
9900-05 Appendix to certificate No. 9900 Accreditation No. ISO 15189 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 09.03.2014 Version No. 2 Page No. 8 of: 17
The certificate attached is an integral part of the schedule and is numbered identicallyצורפת לנספח זה מהווה חלק בלתי נפרד ממנו ומספרה זהה למספר הנספח התעודה המ
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
Biological Testing, Manual Immunoassays בדיקות ביולוגיות, שיטות אימונוכימיות ידניות
67 A P Sodium output Sodium output Urine 24 h
Calculation Cobas 6000 c501 שעות 42איסוף שתן ---
68 A P Transferrin Transferrin Serum סרום Immunoturbidimetric Cobas 6000 c501 ---
69 A P Triglycerides Triglycerides Serum סרום Enzymatic, spectrophotometric Cobas 6000 c501 ---
70 A P Urea Urea Serum סרום Spectrophotometric Cobas 6000 c501 ---
71 A P Urea Urea Urine שתן Spectrophotometric Cobas 6000 c501 ---
72 A P Urea clearance Urea clearance Urine שתן Calculation Cobas 6000 c501 ---
73 A P Urea urine output Urea urine output Urine 24 h שעות 42איסוף שתן Calculation Cobas 6000 c501 ---
74 A P Uric acid Uric acid Serum סרום Spectrophotometric Cobas 6000 c501 ---
75 A P Uric acid Uric acid Urine שתן Spectrophotometric Cobas 6000 c501 ---
9900-05 Appendix to certificate No. 9900 Accreditation No. ISO 15189 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 09.03.2014 Version No. 2 Page No. 9 of: 17
The certificate attached is an integral part of the schedule and is numbered identicallyצורפת לנספח זה מהווה חלק בלתי נפרד ממנו ומספרה זהה למספר הנספח התעודה המ
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
Biological Testing, Microscopy Testing בדיקות ביולוגיות, שיטות במיקרוסקופיה
76 A P Amorphous urates Amorphous urates Urine שתן Microscopy Light Microscope ---
77 A P Casts - erythrocytes Casts - erythrocytes Urine שתן Microscopy Light Microscope ---
78 A P Casts - granular Casts - granular Urine שתן Microscopy Light Microscope ---
79 A P Casts - hemoglobin Casts - hemoglobin Urine שתן Microscopy Light Microscope ---
80 A P Casts - hyaline Casts - hyaline Urine שתן Microscopy Light Microscope ---
81 A P Casts - leukocytes Casts - leukocytes Urine שתן Microscopy Light Microscope ---
82 A P Crystals גבישים Urine שתן Microscopy Light Microscope ---
83 A P Mucus יר ר Urine שתן Microscopy Light Microscope ---
84 A P Oxalates Oxalates Urine שתן Microscopy Light Microscope ---
85 A P RBC (Red Blood Cells) תאי דם אדומים Urine
Microscopy Light Microscope שתן
---
9900-05 Appendix to certificate No. 9900 Accreditation No. ISO 15189 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 09.03.2014 Version No. 2 Page No. 10 of: 17
The certificate attached is an integral part of the schedule and is numbered identicallyצורפת לנספח זה מהווה חלק בלתי נפרד ממנו ומספרה זהה למספר הנספח התעודה המ
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
Biological Testing, Microscopy Testing ולוגיות, שיטות במיקרוסקופיהבדיקות בי
86 A P Squamous epithelial cells Squamous epithelial
cells
Urine שתן Microscopy Light Microscope ---
87 A P Urothelial cells Urothelial cells Urine שתן Microscopy Light Microscope ---
88 A P WBC (White Blood
Cells)
Microscopy Light Microscope שתן Urine תאי דם לבנים---
9900-05 Appendix to certificate No. 9900 Accreditation No. ISO 15189 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 09.03.2014 Version No. 2 Page No. 11 of: 17
The certificate attached is an integral part of the schedule and is numbered identicallyצורפת לנספח זה מהווה חלק בלתי נפרד ממנו ומספרה זהה למספר הנספח התעודה המ
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
89 A P CRP (C-reactive Protein )
– (High Sensitivity) CRP (C-reactive Protein ) – (High Sensitivity)
Serum סרום Chemiluminescence Immulite 2000 ---
90 A P Ferritin Ferritin Serum סרום
Chemiluminescence Immulite 2000 ---
91 A P Folic acid חומצה פולית Serum סרום
Chemiluminescence Immulite 2000 ---
92 A P Vitamin B12 Vitamin B12 Serum סרום
Chemiluminescence Immulite 2000 ---
9900-05 Appendix to certificate No. 9900 Accreditation No. ISO 15189 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 09.03.2014 Version No. 2 Page No. 12 of: 17
The certificate attached is an integral part of the schedule and is numbered identicallyצורפת לנספח זה מהווה חלק בלתי נפרד ממנו ומספרה זהה למספר הנספח התעודה המ
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 - Endocrinology :אנדוקרינולוגיה -בריאות, רפואה משפחת מוצרים
Biological Testing, Immunoassays by Autoanalysers בדיקות ביולוגיות, שיטות אימונוכימיות באוטואנלייזרים
93 A P -hCG (- human Chorionic Gonadotropin)
-hCG (- human Chorionic
Gonadotropin)
Serum סרום Chemiluminescence Immulite 2000
---
94 A P C-peptide C-peptide Serum סרום Chemiluminescence Immulite 2000 ---
95 A P TSH (Thyroid
Stimulating Hormone)
TSH (Thyroid
Stimulating Hormone)
Serum סרום Chemiluminescence Immulite 2000 ---
96 A P Vitamin B12 Vitamin B12 Serum סרום Electrochemiluminescence Cobas 6000 e601 ---
97 A P Folic acid חומצה פולית Serum סרום Electrochemiluminescence Cobas 6000 e601 ---
98 A P Estradiol Serum סרום Electrochemiluminescence Cobas 6000 e601 ---
99 A P FSH FSH Serum סרום Electrochemiluminescence Cobas 6000 e601 ---
100 A P LH LH Serum סרום Electrochemiluminescence Cobas 6000 e601 ---
101 A P Progesterone פרוגסטרון Serum סרום Electrochemiluminescence Cobas 6000 e601 ---
102 A P Prolactin Prolactin Serum סרום Electrochemiluminescence Cobas 6000 e601 ---
103 A P ßHCG (Beta human
chorionic gonadotropin)
ßHCG (Beta human
chorionic gonadotropin)
Serum סרום Electrochemiluminescence Cobas 6000 e601 ---
9900-05 Appendix to certificate No. 9900 Accreditation No. ISO 15189 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 09.03.2014 Version No. 2 Page No. 13 of: 17
The certificate attached is an integral part of the schedule and is numbered identicallyצורפת לנספח זה מהווה חלק בלתי נפרד ממנו ומספרה זהה למספר הנספח התעודה המ
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 - Endocrinology :אנדוקרינולוגיה -בריאות, רפואה משפחת מוצרים
Biological Testing, Immunoassays by Autoanalysers בדיקות ביולוגיות, שיטות אימונוכימיות באוטואנלייזרים
104 A P PSA ( Prostate-specific
antigen)
PSA ( Prostate-specific
antigen)
Serum סרום Electrochemiluminescence Cobas 6000 e601 ---
105 A P Ferritin Ferritin Serum סרום Electrochemiluminescence Cobas 6000 e601 ---
106 A P CEA (Carcinoembryonic
antigen)
CEA
(Carcinoembryonic antigen)
Serum סרום Electrochemiluminescence Cobas 6000 e601 ---
107 A P FT4 FT4 Serum סרום Electrochemiluminescence Cobas 6000 e601 ---
108 A P T3 (Triiodothyronine) T3 (Triiodothyronine) Serum סרום Electrochemiluminescence Cobas 6000 e601 ---
109 A P FT3 FT3 Serum סרום Electrochemiluminescence Cobas 6000 e601 ---
110 A P TSH (Thyroid
Stimulating Hormone)
TSH (Thyroid
Stimulating Hormone)
Serum סרום Electrochemiluminescence Cobas 6000 e601 ---
111 A P Insulin אינסולין Serum סרום Electrochemiluminescence Cobas 6000 e601 ---
112 A P Cortisol קורטיזול Serum סרום Electrochemiluminescence Cobas 6000 e601 ---
113 A P AFP AFP Serum סרום Electrochemiluminescence Cobas 6000 e601 ---
114 A P CA-125 (carcinoma
antigen 125)
CA-125 (carcinoma
antigen 125)
Serum סרום Electrochemiluminescence Cobas 6000 e601 ---
9900-05 Appendix to certificate No. 9900 Accreditation No. ISO 15189 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 09.03.2014 Version No. 2 Page No. 14 of: 17
The certificate attached is an integral part of the schedule and is numbered identicallyצורפת לנספח זה מהווה חלק בלתי נפרד ממנו ומספרה זהה למספר הנספח התעודה המ
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 - Endocrinology :אנדוקרינולוגיה -בריאות, רפואה משפחת מוצרים
Biological Testing, Immunoassays by Autoanalysers בדיקות ביולוגיות, שיטות אימונוכימיות באוטואנלייזרים
115 A P CA15-3 (Carcinoma
Antigen 15-3)
CA15-3 (Carcinoma
Antigen 15-3)
Serum סרום Electrochemiluminescence Cobas 6000 e601 ---
116 A P CA19-9 (Carcinoma
Antigen 19-9)
CA19-9 (Carcinoma
Antigen 19-9)
Serum סרום Electrochemiluminescence Cobas 6000 e601 ---
117 A P Testosterone טסטוסטרון Serum סרום Electrochemiluminescence Cobas 6000 e601 ---
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 -בריאות, רפואה משפחת מוצרים
Biological Testing, Blood Cell Typing Manual Smear בדיקות ביולוגיות, אפיון תאי דם, משטח ידני
118 A P Blast Cells Blast Cells Whole blood דם מלא Microscopy Manual blood smear
Giemsa stain ---
119 A P Reticulocyte Count Reticulocyte Count Whole blood דם מלא Microscopy Manual blood smear
Bromo cresyl blue stain ---
120 A P Stabs )bands( Stabs )bands( Whole blood דם מלא Microscopy
Giemsa Stain
Manual blood smear ---
9900-05 Appendix to certificate No. 9900 Accreditation No. ISO 15189 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 09.03.2014 Version No. 2 Page No. 15 of: 17
The certificate attached is an integral part of the schedule and is numbered identicallyצורפת לנספח זה מהווה חלק בלתי נפרד ממנו ומספרה זהה למספר הנספח התעודה המ
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 :רההמטולוגיה, ספי -בריאות, רפואה משפחת מוצרים
Biological Testing, Blood Count by Autoanalysers בדיקות ביולוגיות, ספירה באוטואנלייזרים
121 A P Basophils Basophils Whole blood דם מלא
Automated cell counter Advia 120, Advia 2120 ---
122 A P Basophils Absolute Basophils Absolute Whole blood דם מלא Automated cell counter Advia 120, Advia 2120 ---
123 A P Eosinophils Eosinophils Whole blood דם מלא
Automated cell counter Advia 120, Advia 2120 ---
124 A P Eosinophils Absolute Eosinophils Absolute Whole blood דם מלא Automated cell counter Advia 120, Advia 2120 ---
125 A P Hematocrit Hematocrit Whole blood דם מלא
Automated cell counter Advia 120, Advia 2120 ---
126 A P Hemoglobin המוגלובין Whole blood דם מלא Automated cell counter Advia 120, Advia 2120 ---
127 A P LUC Absolute LUC Absolute Whole blood דם מלא
Automated cell counter Advia 120, Advia 2120 ---
128 A P LUC (Large Unstained
Cells)
LUC (Large Unstained
Cells)
Whole blood
Automated cell counter Advia 120, Advia 2120 דם מלא---
129 A P Lymphocytes Lymphocytes Whole blood דם מלא Automated cell counter
Advia 120, Advia 2120 ---
130 A P Lymphocytes Absolute Lymphocytes Absolute Whole blood
Automated cell counter Advia 120, Advia 2120 דם מלא
--
9900-05 Appendix to certificate No. 9900 Accreditation No. ISO 15189 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 09.03.2014 Version No. 2 Page No. 16 of: 17
The certificate attached is an integral part of the schedule and is numbered identicallyצורפת לנספח זה מהווה חלק בלתי נפרד ממנו ומספרה זהה למספר הנספח התעודה המ
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 בדיקות ביולוגיות, ספירה באוטואנלייזרים
131 A P MCH (Mean Cell
Hemoglobin)
MCH (Mean Cell
Hemoglobin)
Whole blood דם מלא Automated cell counter Advia 120, Advia 2120 ---
132 A P MCHC (Mean Cell
Hemoglobin Concentration)
MCHC (Mean Cell
Hemoglobin Concentration)
Whole blood דם מלא Automated cell counter Advia 120, Advia 2120 ---
133 A P MCV (Mean Cell
Volume)
MCV (Mean Cell
Volume)
Whole blood דם מלא Automated cell counter Advia 120, Advia 2120 ---
134 A P Monocytes Monocytes Whole blood דם מלא Automated cell counter Advia 120, Advia 2120 ---
135 A P Monocytes Absolute Monocytes Absolute Whole blood דם מלא Automated cell counter Advia 120, Advia 2120 ---
136 A P MPV (Mean Platelet
Volume)
MPV (Mean Platelet
Volume)
Whole blood דם מלא Automated cell counter Advia 120, Advia 2120 ---
137 A P Neutrophils
(Polymorphonuclears)
Neutrophils
(Polymorphonuclears)
Whole blood דם מלא Automated cell counter Advia 120, Advia 2120 ---
138 A P Neutrophils Absolute Neutrophils Absolute Whole blood דם מלא Automated cell counter Advia 120, Advia 2120 ---
139 A P PLT (Platelets) PLT (Platelets) Whole blood דם מלא Automated cell counter Advia 120, Advia 2120 ---
140 A P RBC (Red Blood Cell) תאי דם אדומים Whole blood דם מלא
Automated cell counter Advia 120, Advia 2120
---
9900-05 Appendix to certificate No. 9900 Accreditation No. ISO 15189 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 09.03.2014 Version No. 2 Page No. 17 of: 17
The certificate attached is an integral part of the schedule and is numbered identicallyצורפת לנספח זה מהווה חלק בלתי נפרד ממנו ומספרה זהה למספר הנספח התעודה המ
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 בדיקות ביולוגיות, ספירה באוטואנלייזרים
141 A P RDW (Red Blood Cell
Distribution Width)
RDW (Red Blood Cell
Distribution Width)
Whole blood דם מלא Automated cell counter Advia 120, Advia 2120 ---
142 A P WBC (White Blood
Cells)
Automated cell counter Advia 120, Advia 2120 דם מלא Whole blood תאי דם לבנים---
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 -אות, רפואה ברימשפחת מוצרים
Biological Testing, Autoanalysers ,שיטות באוטואנלייזרים בדיקות ביולוגיות
143 A P Fibrinogen פיברינוגן Plasma פלסמה Modified thrombin time Sysmex CA 1500 ---
144 A P INR (International
Normalizing Ratio)
INR (International
Normalizing Ratio)
Plasma פלסמה Calculation Sysmex CA 1500 ---
145 A P PT (ProthrombinTime) PT (ProthrombinTime) Plasma פלסמה Clot detection photometry Sysmex CA 1500 ---
146 A P PTT (Partial Thromboplastin Time)
PTT (Partial Thromboplastin Time)
Plasma פלסמה
Clot detection photometry Sysmex CA 1500 ---
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