TÜRK AKREDİTASYON KURUMU       

Turkish Accreditation Agency

ACCREDITATION CERTIFICATE
Operating as a Medical Testing Laboratory,

ÖZKAYA LABORATORY SYSTEMS HEALTH SERVICES MEDICAL TRADE LIMITED COMPANY

Head Office Address: REMZİ OĞUZ ARIK MAH. ATATÜRK BLV. UĞURLU APT. NO:237/27 ÇANKAYA, Ankara / Turkey




As a result of the audit conducted by TÜRKAK, the laboratory has been accredited according to the TS EN ISO 15189:2013 standard for the scopes provided in the Annex.


Accreditation Number: AB-0012-TL

Accreditation Date: 01.03.2013

Revision Date / No: 18.07.2024 / 07


This Certificate is valid until 21.06.2025, provided the organization specified above maintains compliance with the TS EN ISO 15189:2013 Standard, relevant Regulations, and Notifications.

Gülden Banu Müderri̇soğlu
Secretary General


The Turkish Accreditation Agency (TÜRKAK) has signed multilateral agreements (MLA/MRA) with the European Accreditation (EA) and the International Laboratory Accreditation Cooperation (ILAC) in the field of ISO 15189.
7460b0f6-926f-4ae5-adf9-649d625d3baf_6bf2f849-fbdc-4113-6e41-08d677a29ad4 3
 


Medical Testing
TS EN ISO 15189
AB-0012-TL
ÖZKAYA LABORATORY SYSTEMS HEALTH SERVICES MEDICAL TRADE LIMITED COMPANY


Accreditation No: AB-0012-TL
Revision No: 07 Date: 18.07.2024
Medical Testing Laboratory
  Address:
REMZİ OĞUZ ARIK MAH. ATATÜRK BLV. UĞURLU APT. NO:237/27 ÇANKAYA Ankara / Turkey
Phone
: +90 312 427 8585
Fax
: +90 312 427 8580
Email
: oyaozdemir@viromed.com.tr
Website
Medical Field, Examined/Tested Products or Materials Experiment-Test-Parameter Test Methods (National, International Standards, Internal Methods (SOP)/Techniques/Devices Used) Primary Sample
Serum, Plasma
Glucose




"Colorimetric"

SOP PR 19/Rev. No.00


ROCHE COBAS C501

Blood
Serum, Plasma
Urea

Kinetic Colorimetric


SOP PR 22/Rev. No.00


ROCHE COBAS C501

Blood

Serum

Kreatinin




Kinetic Colorimetric


SOP PR 31/Rev. No.00


ROCHE COBAS C501

Blood
Serum
Creatine Kinase

Photometric

SOP PR 30./Rev. No. 00

ROCHE COBAS C501

Blood
Serum
Ürik Asit

Enzymatic Colorimetric

SOP PR 40/Rev. No.00

ROCHE COBAS C501

Blood

Serum

Kalsiyum (Ca)




Colorimetric Photometric


SOP PR 29/Rev. No.00


ROCHE COBAS C501

Blood

Serum

Fosfor (P)




Photometric


SOP PR 32/Rev. No.00


ROCHE COBAS C501

Blood

Serum
Total Protein




Colorimetric Photometric


SOP PR 39/Rev. No.00


ROCHE COBAS C501

Blood

Serum, Plasma

Albumin




Colorimetric


SOP PR 18/Rev. No.00


ROCHE COBAS C501

Blood
Serum, Plasma

Kolesterol




Colorimetric


SOP PR 20/Rev. No.00


ROCHE COBAS C501

Blood
Serum, Plasma
Trigliserit




Colorimetric


SOP PR 21/Rev. No.00


ROCHE COBAS C501

Blood

Serum

HDL




Colorimetric


SOP PR 34/Rev. No.00


ROCHE COBAS C501

Blood

Serum

Amilaz




Colorimetric


SOP PR 26/Rev. No.00


ROCHE COBAS C501

Blood

Serum

Lipaz





Colorimetric Photometric


SOP PR 37/Rev. No.00


ROCHE COBAS C501

Blood
Serum, Plasma
AST




Kinetic Colorimetric


SOP PR 23/Rev. No.00


ROCHE COBAS C501

Blood

Serum

ALT




Kinetic Colorimetric


SOP PR 25/Rev. No.00


ROCHE COBAS C501

Blood

Serum

LDH




Photometric


SOP PR 36/Rev. No.00


ROCHE COBAS C501

Blood

Serum

Total Bilirubin




Colorimetric (DİAZO)


SOP PR 28/Rev. No.00


ROCHE COBAS C501

Blood
Serum
ALP





Colorimetric


SOP PR 24/Rev. No.00


ROCHE COBAS C501

Blood

Serum

GGT




Enzymatic Colorimetric


SOP PR 33/Rev. No.00


ROCHE COBAS C501

Blood

Serum

Direkt Bilirubin




Colorimetric (DİAZO)


SOP PR 27/Rev. No.00


ROCHE COBAS C501

Blood

Serum

Magnezyum (Mg)




Colorimetric


SOP PR 38/Rev. No.00


ROCHE COBAS C501

Blood

Serum
Demir (Fe)




Colorimetric


SOP PR 35/Rev. No.00


ROCHE COBAS C501

Blood
Tam Blood
HbA1c




Türbidimetrik İnhibisyon İmmünolojik


SOP PR 85/Rev. No.00


ROCHE COBAS C-501

Blood
Serum
Lityum (Li)





Colorimetric


SOP PR 74/Rev. No.00


ROCHE COBAS C-501

Blood
Serum
Alfa-1 Antitripsin




İmmünotürbidimetrik


SOP PR 82/Rev. No.00


ROCHE COBAS C-501

Blood
Serum
Seruloplazmin





İmmünotürbidimetrik


SOP PR 83/Rev. No.00


ROCHE COBAS C-501

Blood
Serum
Transferrin





İmmünotürbidimetrik


SOP PR 75/Rev. No.00


ROCHE COBAS C-501

Blood
Serum
IgA





İmmunoturbidimetrik


SOP PR 79/Rev. No.00


ROCHE COBAS C-501

Blood
Serum
IgG





İmmunoturbidimetrik


SOP PR 81/Rev. No.00


ROCHE COBAS C-501

Blood
Serum
IgM





İmmunoturbidimetrik


SOP PR 80/Rev. No.00


ROCHE COBAS C-501

Blood

Serum

Serbest T3





ECLIA


SOP PR 57/Rev. No.00


ROCHE COBAS E-801

Blood

Serum

Serbest T4





ECLIA


SOP PR 58/Rev. No.00


ROCHE COBAS E-801

Blood
Serum
TSH





ECLIA


SOP PR 68/Rev. No.00


ROCHE COBAS E-801

Blood

Serum

FSH





ECLIA


SOP PR 56/Rev. No.00


ROCHE COBAS E-801

Blood

Serum

LH





ECLIA


SOP PR 62/Rev. No.00


ROCHE COBAS E-801

Blood

Serum

Prolaktin





ECLIA


SOP PR 63/Rev. No.


ROCHE COBAS E-801

Blood

Serum

Estradiol E2





ECLIA


SOP PR 51/Rev. No.00


ROCHE COBAS E-801

Blood
Serum
Progesteron





ECLIA


SOP PR 64/Rev. No.00


ROCHE COBAS E-801

Blood

Serum

Total Testosteron




ECLIA


SOP PR 66/Rev. No.00


ROCHE COBAS E-801

Blood

Serum

Beta HCG





ECLIA


SOP PR 59/Rev. No.00


ROCHE COBAS E-801

Blood
Serum
Total PSA





ECLIA


SOP PR 49/Rev. No.00


ROCHE COBAS E-801

Blood
Serum
Serbest PSA





ECLIA


SOP PR 50/Rev. No.00


ROCHE COBAS E-801

Blood

Serum

AFP





ECLIA


SOP PR 45/Rev. No.00


ROCHE COBAS E-801

Blood

Serum
CEA





ECLIA


SOP PR 48/Rev. No.00


ROCHE COBAS E-801

Blood

Serum

CA 15-3




ECLIA


SOP PR 47/Rev. No.00


ROCHE COBAS E-801

Blood

Serum

CA 125





ECLIA


SOP PR 46/Rev. No.


ROCHE COBAS E-801

Blood

Serum

CA 19-9





ECLIA


SOP PR 72/Rev. No.00


ROCHE COBAS E-801

Blood

Serum

Vitamin B12





ECLIA


SOP PR 41/Rev. No.00


ROCHE COBAS E-801

Blood

Serum

Folik Asit





ECLIA


SOP PR 43/Rev. No.


ROCHE COBAS E-801

Blood

Serum

Ferritin





ECLIA


SOP PR 42/Rev. No.00


ROCHE COBAS E-801

Blood
Serum
İnsülin





ECLIA


SOP PR 61/Rev. No.00


ROCHE COBAS E-801

Blood

Serum

PTH





ECLIA


SOP PR 44/Rev. No.00


ROCHE COBAS E-801

Blood

Serum

25-Hidroksivitamin D





ECLIA


SOP PR 69/Rev. No.00


ROCHE COBAS E-411

Blood

Serum

Kortizol





ECLIA


SOP PR 54/Rev. No.00


ROCHE COBAS E-801

Blood

Serum

DHEA-SO4





ECLIA


SOP PR 55/Rev. No.00


ROCHE COBAS E-801

Blood
Serum
C-Peptid





ECLIA


SOP PR 53/Rev. No.00


ROCHE COBAS E-801

Blood
Serum
Seks Hormonu Bağlayıcı Globulin (SHBG)





ECLIA


SOP PR 65/Rev. No.00


ROCHE COBAS E-801

Blood
Serum
Tiroglobulin





ECLIA


SOP PR 67/Rev. No.00


ROCHE COBAS E-801

Blood
Serum
Total IgE





ECLIA


SOP PR 60/Rev. No.00


ROCHE COBAS E-801

Blood

Tam Blood (EDTA)

Hemoglobin





Siyanomethemoglobin


SOP PR 86/Rev. No.00


SYSMEX XN 1000

Blood

Tam Blood (EDTA)

Hematokrit





Empedans


SOP PR 86/Rev. No. 00


SYSMEX XN 1000

Blood

Plasma (Citrated)

PT





Koagülometrik


SOP PR 91/Rev. No.00


AMAX 200

Blood

Plasma (Citrated)

APTT





Koagülometrik


SOP PR 111/Rev. No.00


AMAX 200

Blood
Serum
Karbamazepin





Mikropartikül Aglütinasyon


SOP PR 71/Rev. No.00


ROCHE COBAS C-501

Blood
Serum
Valproik Asit





İmmunolojik


SOP PR 70/Rev. No.00


ROCHE COBAS C-501

Blood

Serum

Kompleman C3



İmmünotürbidimetrik


SOP PR 76/Rev. No.00


ROCHE COBAS C-501

Blood

Serum

Kompleman C4



İmmünotürbidimetrik


SOP PR 77/Rev. No.00


ROCHE COBAS C-501

Blood

Serum

Büyüme Hormonu (GH)



ECLIA


SOP PR 52/Rev. No.00


ROCHE COBAS E-801

Blood

Serum

C Reaktif Protein (CRP)



İmmünotürbidimetrik


SOP PR 84/Rev. No.00


ROCHE COBAS C-501

Blood

Tam Blood (EDTA)

HbA1c





HPLC


SOP PR 92/Rev. No.00


BIORAD VARIANT II TURBO

Blood

Tam Blood (EDTA)

WBC





Empedans


SOP PR 86/Rev. No.00


SYSMEX XN 1000

Blood

Tam Blood (EDTA)

RBC





Empedans


SOP PR 86/Rev. No.00


SYSMEX XN 1000

Blood

Tam Blood (EDTA)

PLT





Empedans


SOP PR 86/Rev. No.00


SYSMEX XN 1000

Blood

Tam Blood (EDTA)

MCV





Empedans


SOP PR 86/Rev. No.00


SYSMEX XN 1000

Blood

Tam Blood (EDTA)

MCH





Empedans


SOP PR 86/Rev. No.00


SYSMEX XN 1000

Blood

Tam Blood (EDTA)

MCHC





Empedans


SOP PR 86/Rev. No.00


SYSMEX XN 1000

Blood

Serum

Beta HCG





CLIA


SOP PR 78/ Rev. No.00


BECKMAN COULTER ACCESS 2

Blood
Serum


Estriol (E3)



CLIA


SOP PR 93/ Rev. No.00


BECKMAN COULTER ACCESS 2

Blood

Serum

Kolinesteraz


Colorimetric


SOP PR 73/Rev. No.00


ROCHE COBAS C-501

Blood

Plasma (Citrated)

INR





Koagülometrik


SOP PR 91./Rev. No.00


AMAX 200

Blood
 
Abbreviations

P: Pending

W/D: Withdrawal
 


Medical Experiment
TS EN ISO 15189
AB-0012-TL
ÖZKAYA LABORATORY SYSTEMS HEALTH SERVICES MEDICAL TRADE COMPANY LIMITED


Accreditation Number: AB-0012-TL
Revision No: 07 Date: 18.07.2024
Medical Field, Products or Materials Examined / Tested Experiment-Test-Parameter Test Method (National, International Standards, In-House Methods (SOP) / Techniques / Devices Used Primary Sample

Serum

HIV 1/2 Antibodies and HIV1 P24 Antigen Detection




ECLIA


SOP PR 90/Rev. No. 00


ROCHE COBAS E-411

Blood
Serum

Cytomegalovirus (CMV) IgG Antibody Detection




ECLIA Method


SOP PR 105/Rev. No. 00


ROCHE COBAS E-411

Blood
Serum

Cytomegalovirus (CMV) IgM Antikoru Detection



ECLIA Method


SOP PR 104/Rev. No.00


ROCHE COBAS E-411

Blood

Serum

Anti Herpes simplex Tip 1 Virus (HSV-1) IgG Antikoru Detection




ELISA Yöntemi


SOP PR 109/Rev. No. 00


AWARENESS CHROMATE-

HUMAN COMBIWASH

Blood

Serum

Anti Herpes Simplex Tip 2 Virus (HSV-2) IgG Antikoru Detection




ELISA Yöntemi

SOP PR 110/Rev. No.00


AWARENESS CHROMATE-

HUMAN COMBIWASH

Blood
Serum

Anti Rubella IgG Antikoru Detection




ECLIA Method


SOP PR 103 /Rev. No.00


ROCHE COBAS E-411

Blood
Serum

Anti Rubella IgM Antikoru Detection




ECLIA Method

SOP PR 102/Rev. No.00


ROCHE COBAS E-411

Blood
Serum

Anti-HAV IgG Detection




ECLIA Method


SOP PR 99/Rev. No.00


ROCHE COBAS E-411

Blood
Serum

Anti-HBc IgG Detection




ECLIA Method


SOP PR 97/Rev. No.00



ROCHE COBAS E-411

Blood
Serum

Anti-HBc IgM Detection




ECLIA Method

SOP PR 96/Rev. No.00



ROCHE COBAS E-411

Blood
Serum

Anti-HAV IgM Detection





ECLIA Method


SOP PR 98/Rev. No.00



ROCHE COBAS E-411

Blood
Serum

Anti-HCV Testi




ECLIA Method


SOP PR 88/Rev. No.00


ROCHE COBAS E-411

Blood
Serum

Toxoplasma IgG




ECLIA Method

SOP PR 101/Rev. No.00



ROCHE COBAS E-411

Blood
Serum

Toxoplasma IgM




ECLIA Method

SOP PR 100/Rev. No.00



ROCHE COBAS E-411

Blood

Serum

Anti-Hbs Detection




ECLIA Method

SOP PR 87/Rev. No.00


ROCHE COBAS E-411

Blood

Serum

EBV-VCA IgG



ELISA Yöntemi


SOP PR 107/Rev. No.00


AWARENESS CHROMATE-

HUMAN COMBIWASH

Blood

Serum

EBV-VCA IgM




ELISA Yöntemi


SOP PR 108/Rev. No.00


AWARENESS CHROMATE-

HUMAN COMBIWASH

Blood

Serum

HBsAg Detection




ECLIA Method


SOP PR 106/Rev. No.00


ROCHE COBAS E-411

Blood

Serum

Anti-Hbe Detection




ECLIA Method


SOP PR 95/Rev. No.00



ROCHE COBAS E-411

Blood

Serum

HBeAg Detection






ECLIA Method


SOP PR 94/Rev. No.00



ROCHE COBAS E-411

Blood

Serum

SYPHİLİS (VDRL)

ECLIA

SOP PR 89 / Rev. No. 00

ROCHE COBAS E-411

Blood

Swab

SARS CoV-2 RNA



Real Time PCR

SOP PR 112 / Rev. No.00

BIORAD CFX96

Nazofaringeal, Orofaringeal Swab

 
Abbreviations

P: Pending

W/D: Withdrawal
d82a03ee-e11d-4371-a018-67a58859a9a5_6bf2f849-fbdc-4113-6e41-08d677a29ad4_Flex 3
 
Flexible Scope


Medical Experiment
TS EN ISO 15189
AB-0012-TL
ÖZKAYA LABORATORY SYSTEMS HEALTH SERVICES MEDICAL TRADE LIMITED COMPANY


Accreditation No: AB-0012-TL
Revision No: 07 Tarih: 18.07.2024
Medical Experiment Laboratory
  Address :
REMZİ OĞUZ ARIK MAH. ATATÜRK BLV. UĞURLU APT. NO:237/27 ÇANKAYA Ankara / Turkey
Phone
: +90 312 427 8585
Fax
: +90 312 427 8580
Email
: oyaozdemir@viromed.com.tr
Website
Medical Field, Examined / Tested Products or Materials Experiment-Test-Parameter Test Method (National, International Standards, In-house Methods (SOP)/Techniques/Devices Used Primary Sample
2

Serum

Biochemistry Analytes

Colorimetric, Kinetic Colorimetric, Colorimetric Photometric, Photometric, Enzymatic Colorimetric


YNT PR 17


ROCHE COBAS501 

Blood
Flexible Scope: The laboratory may use the following flexible scope parameters, as marked in the scope, in accordance with its approved and documented procedures and adhering to the same measurement technique. For details, see the additional accredited tests list of the laboratory on the TÜRKAK website (https://www.turkak.org.tr)
1Laboratory may add new materials/products to its scope
2Laboratory can add new test parameters to the scope
3Laboratory can make changes to test method performance
4Laboratory can add technical equivalent standard methods to its scope
 
Abbreviations

A: Suspended

IO: Back pull
d82a03ee-e11d-4371-a018-67a58859a9a5_6bf2f849-fbdc-4113-6e41-08d677a29ad4_iadl 3