Indevr, Inc. is one of 5511 FDA 510(k) medical device manufacturers from United States in the dataset, ranked by real submission volume.
Indevr, Inc. - FDA 510(k) Cleared Devices
Recent clearances: FluChip-8G Influenza A+B Assay
1
Total
1
Cleared
0
Denied
Indevr, Inc. is a global leader in analytical technologies for vaccine development and manufacturing. Now part of SSI Diagnostica A/S, the company operates from Boulder, Colorado and specializes in multiplexed immunoassay solutions and automated hemagglutination analysis systems.
Indevr has received 1 FDA 510(k) clearance from 1 total submission. The company's regulatory focus centers on Microbiology devices, with its first and only clearance granted in 2019. The cleared device, FluChip-8G Influenza A+B Assay, reflects the company's core expertise in rapid viral diagnostics. Indevr has been inactive in FDA submissions for more than five years and is maintained as a historical regulatory record.
The company's product portfolio includes the VaxArray Platform for multiplex vaccine potency testing and the CypherOne System for automated hemagglutination and hemagglutination inhibition assay analysis. These technologies support development, optimization, and manufacturing of mRNA, polysaccharide, conjugate, and viral vector vaccines across clinical and commercial stages.
Explore cleared device names, product codes, and detailed clearance dates in the 510(k) database.
FDA 510(k) Regulatory Record - Indevr, Inc.
1 devices