Immunodiagnostic Systems Limited
Active in EUDAMEDUnited Kingdomfrom SRN EUDAMED FDA SRN GB-MF-000015851
- Devices
- 203
- Registrations
- EUDAMEDFDA
- FDA recalls
- 8
Catalogue
IDS-iSYS Cuvettes Ref IS-CC100
IDS ANCA/GBM Control Set Ref IS-AI1730
IDS Specific IgE (F075) Egg yolk Ref IS-1F075
Showing 201-203 of 203
Company details
- EUDAMED SRN
- GB-MF-000015851
- DUNS number
- 494268600
- EUDAMED status
- Active
- EUDAMED registered name
- Immunodiagnostic Systems Limited
- EUDAMED abbreviated name
- IDS
- Registered address
- 10, Didcot Way, Boldon Business Park,, NE35 9PD, Boldon, Tyne & Wear, United Kingdom (ex Northern Ireland)
- Website
- www.idsplc.com
- [email protected]
- Phone
- +44 191 519 0660
- PRRC contact
- Mick Henderson
EUDAMED certificates
1 certificate1 valid, 0 expiredIVDR 1next expiry 26 Aug 2028
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
FDA recalls
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 establishments
- 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.
Frequently asked questions
How many devices does Immunodiagnostic Systems Limited have in the registry?
The registry currently lists 203 devices for Immunodiagnostic Systems Limited. Devices recorded under merged duplicate company entries are counted once.
Are there FDA recall records for Immunodiagnostic Systems Limited?
FDA recall records list 8 recalls initiated by Immunodiagnostic Systems Limited, the most recent initiated on 2012-08-10. A recall is often a precaution started by the manufacturer; the records say nothing about the company's overall record.
What EUDAMED certificates are recorded for Immunodiagnostic Systems Limited?
EUDAMED lists 1 certificate for Immunodiagnostic Systems Limited (quality management system) under IVDR. The most recent was issued on 2025-09-10.
Which FDA establishments are linked to Immunodiagnostic Systems Limited?
1 FDA establishment is linked to Immunodiagnostic Systems Limited in the registry; they are listed on the company page.