Overview
Biohit is a Finnish biotechnology company established in 1988 that specializes in in vitro diagnostic (IVD) devices and automated analysis systems for gastrointestinal disease diagnosis and prevention. The company offers a comprehensive portfolio including GastroPanel blood tests, rapid diagnostic kits, and automated immunoassay analyzers, with manufacturing capabilities including a 25,000 m² facility in Hefei with 200 automated production lines. Biohit serves global markets across 50+ countries with products addressing early diagnosis of gastric diseases, H. pylori infection, lactose intolerance, and laryngopharyngeal reflux, alongside COVID-19 diagnostic tests.
Frequently asked questions
- What are Biohit's core diagnostic products?
- Biohit's primary offerings include GastroPanel (blood-sample based examination for stomach illness diagnosis), Peptest (non-invasive test for laryngopharyngeal reflux), rapid urease tests for H. pylori detection, biopsy quick tests for lactose intolerance diagnosis, and Acetium (targets acetaldehyde in achlorhydric stomachs). The company also developed COVID-19 antigen and antibody tests, with the antibody test receiving US-FDA EUA approval.
- What regulatory certifications and approvals does Biohit hold?
- Biohit Healthcare (Hefei) holds ISO 13485 Quality Management System certification and Medical Device Production License. The company has obtained 20 medical device certificates, including first-in-class chemiluminescence and fluorescence immunochromatography kits for Gastrin-17. COVID-19 antibody tests received US-FDA EUA, and the antigen blood test is noted as the first of its kind globally.
- What are Biohit's manufacturing and automation capabilities?
- Biohit operates a 25,000 m² manufacturing facility in Hefei with 200 fully automated production lines and daily capacity of approximately 10 million tests. The company offers the DS2 automated ELISA processor with full walkaway capability for processing two 96-well microplates, and an Automated Immunoassay Analyzer platform designed as a compact, cost-efficient, completely open system for GastroPanel and other EIA assays.