Ng Biotech - FDA 510(k) Cleared Devices

Ng Biotech, develops and manufactures rapid diagnostic tests for infectious disease detection. Founded in 2012 by pioneers in the rapid test industry, the company operates from Guipry, France with two 5,000 m² industrial facilities. The company specializes in point-of-care diagnostics using a proprietary immunoassay platform, delivering results in minutes from minimal sample volumes.

Ng Biotech has received 2 FDA 510(k) clearances from 2 total submissions since 2019. The company's regulatory portfolio focuses exclusively on Microbiology devices, with recent cleared products targeting antimicrobial resistance detection and infectious disease diagnostics. The latest clearance in 2025 demonstrates continued regulatory activity and product innovation.

The company holds ISO 13485:2016 certification and maintains production capacity exceeding 4 million tests monthly. Product applications span human diagnostics, veterinary medicine, and custom development for international partners. Ng Biotech's cleared devices address critical clinical needs including carbapenemase and ESBL resistance detection.

Explore the company's complete FDA 510(k) submission history, device names, product codes, and clearance dates in the database.

510(k) submissions have been managed by Hardy Diagnostics as regulatory consultant.