Medical Device Manufacturer · US , Blacksburg , VA

Techlab, Inc. - FDA 510(k) Cleared Devices

36 submissions · 36 cleared · Since 1992

Total

Cleared

Denied

Techlab, Inc. designs, develops, and manufactures infectious disease diagnostics in the USA. The company specializes in enteric and microbiology diagnostic products distributed worldwide. Techlab holds ISO 13485 certification and MDSAP approval with FDA registration.

Techlab received 36 FDA 510(k) clearances from 36 total submissions between 1992 and 2019. The company's portfolio is dominated by microbiology devices, representing 83% of submissions. Notable cleared products include tests for Clostridioides difficile, Helicobacter pylori, parasites, and fecal biomarkers. Techlab has not received new clearances since 2019 and is considered inactive for regulatory purposes.

The company was founded in 1989 by researchers from Virginia Tech's Anaerobe Laboratory who developed the first commercial diagnostic reagents for C. difficile disease. Techlab now operates as part of the SSI Diagnostica Group and continues to serve clinical laboratories and healthcare systems globally through its established product portfolio.

Explore the complete regulatory history, device names, product codes, and clearance dates in the 510(k) database.