Mikro-Gen

Mikro-Gen (MIKROGEN GmbH) is a German biotechnology company that develops system solutions for in-vitro diagnostics (IVD). According to its official website, the company describes itself as an internationally operating biotechnology company and a market leader in infection serology, holding numerous patents and cooperating closely with research institutes and other companies. Its stated vision is to preserve health and increase quality of life through safe diagnostics. The company positions itself as a pioneer with more than 30 years of experience. Its product portfolio includes diagnostic assays and automation platforms. Notable offerings include the recom CLIA HEV assay on the KleeYa chemiluminescence platform, the KleeYa platform itself, and the ampli Cube PCR automation solution. Mikro-Gen has also introduced electronic instructions for use (eIFU), making its instructions gradually available digitally. Mikro-Gen operates internationally and serves the healthcare and diagnostics market. The company has been certified according to the IVDR (In Vitro Diagnostic Regulation), a key European regulatory framework for diagnostic products. It also hosts events such as the MIKROGEN Symposium, bringing together experts in diagnostics. As a private company, Mikro-Gen focuses on innovation and quality in diagnostic products. Its headquarters are in Germany, and it markets its solutions worldwide.

Mikro-Gen (MIKROGEN GmbH) is a German biotechnology company that has been operating for more than 30 years, according to its official website. The company describes itself as a pioneer in the field and has established itself as a market leader in infection serology. Over the years, it has developed system solutions for in-vitro diagnostics, holding numerous patents and cooperating with research institutes and other companies. The company has continuously invested in innovation and product quality. It introduced electronic instructions for use (eIFU), making its instructions gradually available digitally. Its product portfolio includes the KleeYa chemiluminescence platform and the ampli Cube PCR automation solution. The recom CLIA HEV assay is available on the KleeYa platform. Mikro-Gen has also been certified according to the IVDR, a key European regulation for in-vitro diagnostic devices. Mikro-Gen hosts the MIKROGEN Symposium, an event for experts in diagnostics. The company operates internationally and aims to preserve health and increase quality of life through safe diagnostics.

• Mikro-Gen has been operating for more than 30 years as a biotechnology company.

• Introduction of electronic instructions for use (eIFU).

• recom CLIA HEV assay made available on the KleeYa chemiluminescence platform.

• Mikro-Gen certified according to IVDR.

• MIKROGEN Symposium held in Hamburg in 2026.

Market leader in infection serology; pioneer with more than 30 years of experience; internationally operating biotechnology company focused on safe diagnostics.

• KleeYa chemiluminescence platform

  A chemiluminescence platform for in-vitro diagnostics.

• ampli Cube

  A PCR automation solution.

• recom CLIA HEV assay

  An assay available on the KleeYa platform.

1. 1Mikrogen: Systemlösungen für In-vitro-Diagnostika | Mikrogenmikrogen.de
2. 2MIKROGEN GmbHwikidata.org