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MDR BİYOUYUMLULUK TEST VE ANALİZ FAALİYETLERİ TİC. A.Ş.
İvedik OSB Mah. 1462 Cad. No: 3/8 Yenimahalle / / ANKARA / TÜRKİYE
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Contact Info: +90 312 372 7474
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Hall: 7
Stand: 735D
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In the medical device and medical product industry, biocompatibility tests have become mandatory according to the MDR (Medical Device Regulaton) in order to ensure that products that come into direct or indirect contact with the human body meet biocompatibility requirements before they are placed on the market. As one of Turkey s leading biocompatibility testing and analysis centers, MDR Biocompatibility Test home Analysis Activities Tic. AŞ., one of the leading biocompatibility testing and analysis centers in Turkey, continues to perform the accredited tests required for the certification of medical devices, pharmaceuticals, cosmetics and medical products produced in the biomedical sector and offered as a service with great competence and reliability. MDR Biocompatibility Test and Analysis Center has Turkey s first biocompatibility laboratory providing testing and consultancy services in 10 areas and was accredited by Türkak on 24.10.2023 with accreditation number AB-1886-T within the scope of TS EN/ISO IEC 170252017 Requirements for the competence of Testing and Calibration Laboratories. Hemolysis Test, Bacterial Endotoxin Test, Stability Test, Cytotoxicity Test, Chromosome Aberration Test, Bacterial Back Mutation AMES Test, Irritation and Skin Sensitivity Test, HPRT Mammalian Cell Forward Mutation Test, Sterility Tests required by our customers are carried out by our expert staff in our state-of-the-art laboratories with an impartial, independent, effective, fast, accurate, reliable policy at a level and quality that meets the requirements of national and international standards.
Cytotoxicity is an in vitro test to determine whether the toxic effects that may be caused by indirect or direct contact of medical devices interacting with the body will cause any cell death.
The AMES test determines whether a chemical is mutagenic. This test is based on the principle that Salmonella typhymurium/Escherichia coli WP2 uvrA strains, which are not capable of synthesizing artificially mutated histidine, undergo a second mutation after treatment with the test compound and gain the ability to synthesize histidine/tryptophan and can reproduce in histidine/tryptophan independent environment.
It is used to detect gene mutations induced by chemical substances. The genetic endpoints used in this test measure a mutation in hypoxanthine guanine phosphoribosyl transferase (HPRT).
It is carried out to evaluate the potential of medical devices and materials to cause systemic acute toxic effects. Endotoxins are complex lipopolysaccharides in the outer cell wall of gram-negative bacteria, responsible for the organization and stability of the cell wall. Bacterial endotoxin LAL (Limulus Amebocyte Lysate) test aims to detect toxic structures in the cell walls of gram negative bacteria. LAL test is performed in accordance with ISO 10993-11 standard.
It is based on the principle of spectrophotometric measurement of the increase in free plasma hemoglobin level released as a result of erythrocyte loss and damage caused by the interaction of the materials used in blood contact devices directly or extracted solution with rabbit blood.
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