Test Area
Biological evaluation of medical devices
- As a GLP-compliant non-clinical test facility for medical devies, we provide biological evaluation services essential for both domestic and international approvals.
Services
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Systemic toxicity
- Acute systemic toxicity
- Repeated exposure systemic toxicity (subacute and subchronic)
- Endotoxin-mediated pyrogenicity
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Implantation
- In subcutaneous tissue
- In muscle
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Hemocompatibility
- In vitro hemocompatibility testing [direct or indirect (extract) method]
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Cytotoxicity
- Test on extracts
- Test by direct contact
- Test by indirect contact
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Genotoxicity
- In vitro test (bacterial reverse mutation assays, chromosome aberration test, test for genemutations in bacteria)
- In vivo test (micronucleus genotoxin)
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Irritation and Skin Sensitization
- Irritation test
a. Animal irritation test by skin exposure
b. Animal irritation test by intracutaneous (intradermal) administration
c. Ocula irritation test
d. Oral mucosa irritation test
- Skin sensitization test
a. Guinea Pig Maximization Test (GPMT)
b. Murine Local Lymph Node Assay (LLNA:BrdU-ELISA, LLNA:BrdU-FCM)
TOP
Corestemchemon Inc