Biocompatibility Testing
Summary:
Biocompatibility Testing
Eurofins Medical Device Testing Lab, 9/2024 – 10/2024
- Intracutaneous Reactivity Test
- Laboratory Study Number 67126, 9/6/2024
- Conclusion: Under the conditions of this study, LJ-ARC (Laryngoscope Junctional-Arterial Restriction Clamp) is considered to be a non-irritant for both the polar and non-polar test article extracts.
- Acute Systemic Toxicity Test in Mice
- Laboratory Study Number 67124, 9/6/2024
- Conclusion: Under the conditions of this study, LJ-ARC meets the requirements of the test.
- Material-Mediated Pyrogen Study in Rabbits
- Laboratory Study Number 67125, 9/6/2024
- Conclusion: Based on the criteria of the protocol and interpretation of the raw data according to USP-NF <151>, the test article, LJ-ARC, meets the requirements for the absence of pyrogens.
- In Vitro Cytotoxicty Assay: Evaluation of Test Articles by the MEM Elution Test
- Laboratory Study Number 67127, 9/6/2024
- Conclusion: Based on the criteria of the protocol, the test article, LJ-ARC (Laryngoscope Junctional-Arterial Restriction Clamp), is not considered cytotoxic according to the MEM Elution Test.
- Sensitization Test in Guinea Pig Maximization Model
- Laboratory Study Number 67128, 10/7/2024
- Conclusion: Based on the evaluation system used, LJ-ARC is not considered to be a contact sensitizer.
