Test Classification Current Value

The performance characteristics of the listed assay was validated by BioAgilytix Diagnostics. The US FDA has not approved or cleared this test. The results of this assay can be used for clinical diagnosis without FDA approval. BioAgilytix Diagnostics is a CLIA certified, CAP accredited laboratory for performing high complexity assays such as this one.

Test Classification Value Prior to 3/19/2021 5:02am

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