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Immunodiagnostic Systems Limited

United Kingdom (ex Northern Ireland) GB-MF-000015851 Last updated 27 May 2026

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Devices
203
Registries
EUDAMEDFDA 510(k)GUDIDFDA
FDA recalls
8

Catalogue203

Page 1 of 5

Showing 1-50 of 203

EUDAMED certificates1

Held under this manufacturer's EUDAMED registration, grouped by notified body; in force first, then by expiry.

EUDAMED certificates (1)

TÜV Rheinland LGA Products GmbH 0197 1 certificate

  • HX 2333083-1 Supplemented

    Quality management system EU IVDR

    Issued
    10 Sep 2025
    Expires
    26 Aug 2028
    Reason
    Other

Related companies

Authorised representatives

FDA recalls8

Recalls this firm reported to the FDA. Device pages show the recalls that name the device or the 510(k)/PMA it was cleared under.

  • 2012

    • 10 Aug 2012 Z-0039-2013 Class II Terminated It has been noted by staff at IDS Inc. that stock of the affected products held at IDS Inc. are labeled with IVD labels although they are not registered for sale as IVDs in the United States. The products should have been labeled as Research Use Only or Investigational use only dependent on their usage.
    • 10 Aug 2012 Z-0040-2013 Class II Terminated It has been noted by staff at IDS Inc. that stock of the affected products held at IDS Inc. are labeled with IVD labels although they are not registered for sale as IVDs in the United States. The products should have been labeled as Research Use Only or Investigational use only dependent on their usage.
    • 10 Aug 2012 Z-0041-2013 Class II Terminated It has been noted by staff at IDS Inc. that stock of the affected products held at IDS Inc. are labeled with IVD labels although they are not registered for sale as IVDs in the United States. The products should have been labeled as Research Use Only or Investigational use only dependent on their usage.
    • 10 Aug 2012 Z-0042-2013 Class II Terminated It has been noted by staff at IDS Inc. that stock of the affected products held at IDS Inc. are labeled with IVD labels although they are not registered for sale as IVDs in the United States. The products should have been labeled as Research Use Only or Investigational use only dependent on their usage.
    • 10 Aug 2012 Z-0043-2013 Class II Terminated It has been noted by staff at IDS Inc. that stock of the affected products held at IDS Inc. are labeled with IVD labels although they are not registered for sale as IVDs in the United States. The products should have been labeled as Research Use Only or Investigational use only dependent on their usage.
    • 10 Aug 2012 Z-0044-2013 Class II Terminated It has been noted by staff at IDS Inc. that stock of the affected products held at IDS Inc. are labeled with IVD labels although they are not registered for sale as IVDs in the United States. The products should have been labeled as Research Use Only or Investigational use only dependent on their usage.
    • 10 Aug 2012 Z-0045-2013 Class II Terminated It has been noted by staff at IDS Inc. that stock of the affected products held at IDS Inc. are labeled with IVD labels although they are not registered for sale as IVDs in the United States. The products should have been labeled as Research Use Only or Investigational use only dependent on their usage.

  • 2008

    • 2 Aug 2008 Z-0173-2009 Unclassified (pre-2012) Terminated A small number of customers have experienced low absorbance values when using kits from this batch.

FDA establishments1

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

  • Immunodiagnostic Systems, Ltd. US

What Immunodiagnostic Systems Limited makes

Immunodiagnostic Systems Limited manufactures a range of in vitro diagnostic (IVD) reagents and kits, including solutions for rheumatoid arthritis testing, hormone assays such as Androstenedione, vitamin D measurement kits, and a series of specific IgE test kits for allergens like cow's milk, pistachio, soybean, plantain, meadow fescue, and rye‑grass. The portfolio also includes control sets for IgM, a total/specific IgE reagent kit, and a calibrator set for the Beta CrossLaps (CTX‑I) assay.

These products are classified under Class A, Class B, and IVD General categories and are listed in the European Database on Medical Devices (Eudamed). The company is based in the United Kingdom.

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 Immunodiagnostic Systems Limited manufacture?

Immunodiagnostic Systems Limited specialises in in vitro diagnostic (IVD) reagents and kits. These include solutions for detecting rheumatoid arthritis markers like the Zenit RA D-Sorb, hormone assays such as the Androstenedione test, vitamin D measurement kits like the IDS-iSYS 25 VitDS, and a variety of specific IgE test kits for identifying allergies to foods (e.g., cow’s milk, pistachio, soybean) and environmental allergens (e.g., meadow fescue, rye-grass). The company also produces control sets and calibrator reagents for laboratory use.

Where is Immunodiagnostic Systems Limited based?

The company is headquartered in the United Kingdom. Its location is relevant for regulatory compliance and transparency, as it operates within the EU’s medical device framework, which includes obligations like listing devices in Eudamed.

Which regulatory registries list Immunodiagnostic Systems Limited’s devices?

The company’s devices are listed in the European Database on Medical Devices (Eudamed), which is the official EU registry for tracking medical devices authorised under the Medical Device Regulations (MDR) or In Vitro Diagnostic Regulation (IVDR). Listing in Eudamed ensures traceability and compliance with EU requirements.

How are Immunodiagnostic Systems Limited’s devices classified under EU regulations?

The company’s products fall into Class A, Class B, and IVD General classifications. Class A devices are typically low-risk, non-invasive diagnostics like some reagent kits, while Class B includes moderate-risk assays such as specific IgE tests for allergens. IVD General refers to devices not fitting into specific risk classes but still requiring regulatory oversight. Classification determines the level of scrutiny and documentation required for authorisation.

Why does it matter that these devices are listed in Eudamed?

Listing in Eudamed ensures transparency and compliance with EU medical device laws. It allows healthcare professionals, regulators, and authorities to verify that the devices meet legal requirements before use. For example, specific IgE test kits (like those for cow’s milk or rye-grass allergies) must be traceable to confirm their safety and performance, which Eudamed facilitates. This registry also supports post-market surveillance and recall procedures if needed.

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

Information

Country
United Kingdom (ex Northern Ireland)
Address
10, Didcot Way, Boldon Business Park, , Boldon, Tyne & Wear, United Kingdom (ex Northern Ireland)
Phone
+44 191 519 0660
PRRC contact
Mick Henderson
EUDAMED SRN
GB-MF-000015851
DUNS number
494268600