Laboratory Test Request

Catheter Testing (Cytotoxicity, Intracutaneous, Skin Sensitization, Toxicity, Hemolysis,Hemocompatibility, Thrombogenicity, Pyrogen)

Project Description

Medical Device Laboratory needed for multiple testing of balloon dilator catheter and microcatheter, both of which are in direct contact with blood.
The test we plan to do below:
1.In vitro cytotoxicity test< ISO 10993-5 >MTT Assay,
2.Intracutaneous Test ,Polar & nonpolar
3.Skin Sensitization Test in Guniea Pigs (Maximization method), Polar &nonpolar
4.Acute Systemic Toxicity Test in mice , Polar & nonpolar
5.Hemolysis Test
6.Hemocompatibility: Complement Activation, SC5b-9,test or predicate
7.Dog Thrombogenicity, 4 test devices and 4 predicates
8. Pyrogen Test

Project Information

Number:24-00897

Industry:Medical Devices

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