# Immunodiagnostic Systems, Ltd.

- Location (FDA's records): Boldon, Tyne & Wear, GB
- FDA decisions: 27 (1994–2026): 27 510(k) clearances
- Names in FDA's records: Immunodiagnostic Systems , Ltd. (23); Immunodiagnostic Systems Limited (3); Immunodiagnostic Systems, Inc. (1)
- Product codes: MRG (9), JJX (6), CEW (3), CDZ (3), CJM (1), CFL (1), CKG (1), CGR (1), CIN (1), CIB (1)
- 510(k) review time since 2016: median 138 days, against 127 for FDA's reviews in the same codes and years (2 of 4 faster)
- Predicates its devices cite: 16 (8 its own); citations of its devices by later devices: 14 (8 its own)
- Recalls linked to its devices: 2 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Roche Diagnostics Corp.: 4 (https://510kreport.com/company/roche-diagnostics)
- Diagnostic Products Corp.: 1 (https://510kreport.com/company/diagnostic-products)
- Hybritech, Inc.: 1 (https://510kreport.com/company/hybritech)
- Siemens Healthcare Diagnostics, Inc.: 1 (https://510kreport.com/company/siemens-healthcare-diagnostics)
- Monobind: 1 (https://510kreport.com/company/monobind)

## Firms that cite its devices most
- Diazyme Laboratories: 2 (https://510kreport.com/company/diazyme-laboratories)
- Euroimmun Us, Inc.: 1 (https://510kreport.com/company/euroimmun-us)
- Ortho-Clinical Diagnostics, Inc.: 1 (https://510kreport.com/company/ortho-clinical-diagnostics)
- Diasource Immunoassays, S.A.: 1 (https://510kreport.com/company/diasource-immunoassays)
- Siemens Healthcare Diagnostics, Inc.: 1 (https://510kreport.com/company/siemens-healthcare-diagnostics)

## Its most-cited devices
- K021163: Octeia 25-Hydroxy Vitamin D (2002), cited by 6
- K091849: Ids-Isys 25-Hydroxy Vitamin D Assay, Ids-Isys 25-Hydroxy Vitamin D Control Set (2010), cited by 3
- K111650: Ids-Isys CTX-1 (Crosslaps) Calibration Verifiers, Ids-Isys 25 Hydroxy Vitamin D Calibration Verifiers, and Ids-Isys... (2011), cited by 3
- K103325: Ids-Isys Intact PTH (2012), cited by 1
- K140554: Ids-Isys 25-Hydroxy Vitamin DS, and Ids-Isys 25 Hydroxy Vitamin DS Control Set (2014), cited by 1

## Recent decisions
- K252728: IDS-iSYS Total Testosterone (Apr 15, 2026)
- K240865: IDS-iSYS Free Testosterone (Oct 23, 2024)
- K223867: Ids Acth II (Aug 18, 2023)
- K202136: IDS Cortisol (Apr 13, 2021)
- K200475: IDS-iSYS Ostase BAP (Sep 30, 2020)
- K190121: Ids SHBG (Jun 17, 2019)
- K161158: IDS-iSYS Intact PTHN (Jan 31, 2017)
- K161831: IDS-iSYS 25VitDs, IDS-iSYS 25VitDs Control Set (Nov 15, 2016)

Source page: https://510kreport.com/company/immunodiagnostic-systems