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Serosep Limited

Ireland IE-MF-000020322 Last updated 21 Oct 2026

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Devices
27
Registries
EUDAMEDFDA
FDA recalls
0

Catalogue27

FDA establishments1

Registered with the FDA under this company group, matched by name.

  • Serosep, Ltd. IE

About

We are the leading laboratory diagnostics specialists in microbiology, histopathology and environmental testing.

From the manufacturer's own website. Source

What Serosep Limited makes

Serosep Limited manufactures plug-in diagnostic panels for microbiological testing, including EntericBio® and RespiBio® panels designed to detect pathogens such as viruses, bacteria, and gastrointestinal or respiratory infections. The company also produces HistoPot 10% Neutral Buffered Formalin, a fixative solution used in histopathology for tissue preservation. These products are intended for laboratory use in identifying and diagnosing infectious diseases and environmental contaminants.

The company’s diagnostic panels and fixative are classified under Class A and Class B for in vitro diagnostics (IVD), with some products falling under the broader IVD General category. These devices are registered in the EU through the eudamed database, adhering to EU regulatory requirements for medical devices. Serosep Limited is based in Ireland.

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

Information

Country
Ireland
Address
Annacotty Business Park, Limerick, Ireland
Phone
+353 61 358190
PRRC contact
Susan Dwane
EUDAMED SRN
IE-MF-000020322