Analytical Services
We analyze with sensitivity specificity precision accuracy in mind
What We Do
Invitrox organizes performance studies to verify the analytical performance of your IVD. We identify the different specimen types (matrices) that can be used with the IVD and storage and shipping conditions.
The Invitrox Difference
Invitrox ensures the demonstration of analytical performance through dedicated studies aligned with international guidelines for CE marking and FDA approval. We specialize in designing protocols for evaluating analytical performance and securing necessary sites, documentation, and resources to execute these services efficiently and effectively. Our capabilities include organizing studies to verify validate the analytical performance of your In Vitro Diagnostics Medical Device, covering aspects such as analytical sensitivity, specificity, precision, and accuracy.
How We Work
Invitrox conducts all testing services professionally, accurately, and promptly. Additionally, all services comply with applicable state and federal testing requirements for clinical reference laboratories.
Services must be conducted in-house at the Invitrox testing facilities to ensure accurate identification of testing location. Invitrox cannot subcontract services to third-party reference laboratories without prior written consent from the client.
Invitrox is responsible for maintaining all necessary licenses, permits, accreditations, and certifications (collectively referred to as Required Approvals) for itself and its employees throughout the agreement term. These approvals must meet the standards set by applicable laws and accreditation agencies.
Invitrox is responsible for maintaining all necessary licenses, permits, accreditations, and certifications (collectively referred to as Required Approvals) for itself and its employees throughout the agreement term. These approvals must meet the standards set by applicable laws and accreditation agencies.