Test Classification Current Value

The performance characteristics of the listed assays were validated by BioAgilytix Diagnostics. The US FDA has not approved or cleared these tests. The results of these assays can be used for clinical diagnosis without FDA approval. BioAgilytix Diagnostics is a CLIA certified, CAP accredited laboratory for performing high complexity assays.

Test Classification Value Prior to 3/19/2021 5:01am

The performance characteristics of the listed assays were validated by Cambridge Biomedical Inc. The US FDA has not approved or cleared these tests. The results of these assays can be used for clinical diagnosis without FDA approval. Cambridge Biomedical Inc. is a CLIA certified, CAP accredited laboratory for performing high complexity assays.