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DB Biotech, a.s.

Slovakia SK-MF-000051838 Last updated 17 Sep 2026

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Devices
278
Registries
EUDAMED
FDA recalls
0

Catalogue278

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About

Antibodies specially developed for IHC, WB and flow cytometry application. All rabbit clonal antibodies are developed by a novel and proprietary in-vitro cloning technology which has been developed and perfected by the DB Biotech scientific team.

From the manufacturer's own website. Source

What DB Biotech, a.s. makes

DB Biotech produces monoclonal antibodies targeting specific antigens for use in immunohistochemistry (IHC), Western blotting (WB), and flow cytometry. These include Anti-EBV/LMP-1, Anti-CD21, Anti-EGFR, Anti-Chromogranin A, Anti-Human Kappa Light Chain, Anti-EMA (CD227/Mucin-1), Anti-PSA, Anti-CD7, Anti-Human IgG, and Anti-CD8. The antibodies are designed for diagnostic applications in laboratory settings.

The company’s antibody portfolio is classified under EU medical device regulations as Class A and Class C, with devices registered in the EU’s eudamed database. DB Biotech is based in Slovakia.

Written from this company's registered devices by an AI model, and not verified by a human reviewer.

Frequently asked questions

What types of medical devices does DB Biotech, a.s. manufacture?

DB Biotech, a.s. specializes in producing monoclonal antibodies designed for diagnostic use. These antibodies target specific antigens such as EBV/LMP-1, CD21, EGFR, Chromogranin A, and others, and are intended for applications like immunohistochemistry (IHC), Western blotting (WB), and flow cytometry. These products are developed to assist in laboratory-based diagnostic testing.

Where is DB Biotech, a.s. based?

DB Biotech, a.s. is headquartered in Slovakia. The company’s location is relevant for regulatory compliance, as it operates within the EU’s medical device framework, including registration in the eudamed database.

Which regulatory registries list DB Biotech’s devices?

DB Biotech’s medical devices are listed in the eudamed database, which is the official EU registry for medical devices. This registry ensures transparency and traceability of devices authorized under EU medical device regulations.

How are DB Biotech’s devices classified under EU regulations?

DB Biotech’s monoclonal antibodies fall under Class A and Class C classifications in the EU’s medical device regulatory framework. The classification depends on factors like the intended use, risk associated with the device, and the clinical significance of the diagnostic result. Class C devices are typically higher-risk diagnostic products, while Class A devices pose minimal risk.

AI-generated from registry data and not verified by a human reviewer.

Information

Country
Slovakia
Address
80, Popradská, Košice, Slovakia
PRRC contact
Martina Maďarová
EUDAMED SRN
SK-MF-000051838