Microbiology Testing for IVD and Diagnostic Devices
In vitro diagnostic (IVD) devices, sample collection kits, and point-of-care diagnostics have testing requirements that differ from implantable devices — sterility may or may not apply, but bioburden control is often critical for assay accuracy. Boulder BioLabs supports IVD manufacturers with the specific test menu their device class requires.
Tests This Industry Requires
What Makes IVD & Diagnostics Testing Different
IVD devices often present unusual sample geometries — small swabs, plastic test cassettes, lateral flow strips, sample collection tubes. Method selection (extraction technique, recovery efficiency study design) is tuned to the specific device.
Working with IVD Sample Geometries
IVD devices often present unusual sample geometries — small swabs, plastic test cassettes, lateral flow strips, sample collection tubes. Method selection (extraction technique, recovery efficiency study design) is tuned to the specific device.