Data / Medical devices / United Kingdom / Immunodiagnostic Systems Ltd.
Immunodiagnostic Systems Ltd.: FDA-registered device maker in Boldon Colliery Durham, United Kingdom, 27 510(k) clearances
Immunodiagnostic Systems Ltd. is registered with the FDA (registration 8021924) in Boldon Colliery Durham, United Kingdom. It lists 24 device types. The FDA files 27 510(k) clearances under its listings, the newest dated August 21, 2026. 1 recall event names it as the recalling firm. Registered through 2026. FDA data exported November 2, 2026.
SpecStream is the live web data engine for teams and agents. It reads the FDA registration and listing, 510(k), PMA, recall and enforcement files from openFDA every week, and this page is that reading, joined by the FDA's own numbers. Ask for the makers of any device type in any country and new clearances, approvals and recalls arrive in your sheet, CRM, Slack or agent as the FDA publishes them.
- FDA registration number
- 8021924
- FEI number
- 3002485711
- Address
- 10 Didcot Way, Boldon Colliery Durham, United Kingdom, NE35 9PD
- Owner or operator
- IMMUNODIAGNOSTIC SYSTEMS LTD. (8021924)
- Roles
- Manufacturer
- First device listed
- December 8, 2000
- Registered through
- 2026
- Brand names listed
- 1,25-Dihydroxy Vitamin D EIA, 1,25-Dihydroxy Vitamin D RIA, 25-Hydroxy Vitamin D RIA, 25-Hydroxy Vitamin DS EIA, Alpha CrossLaps® (CTX-I) EIA, IDS ACTH II, IDS ACTH II Calibrator Set, IDS ACTH II Control Set and more
Devices it lists
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| August 21, 2026 | K253817 | IDS SS-A/Ro; IDS SS-A/Ro 60 kDa; IDS SS-B/La | LLL | Substantially Equivalent | Immunodiagnostics Systems Limited | accessdata.fda.gov |
| April 15, 2026 | K252728 | IDS-iSYS Total Testosterone | CDZ | Substantially Equivalent | Immunodiagnostic Systems Limited | accessdata.fda.gov |
| October 23, 2024 | K240865 | IDS-iSYS Free Testosterone | CDZ | Substantially Equivalent | Immunodiagnostic Systems Limited | accessdata.fda.gov |
| August 18, 2023 | K223867 | IDS ACTH II | CKG | Substantially Equivalent | Immunodiagnostic Systems Limited | accessdata.fda.gov |
| April 13, 2021 | K202136 | IDS Cortisol | CGR | Substantially Equivalent | Immunodiagnostic Systems , Ltd. | accessdata.fda.gov |
| September 30, 2020 | K200475 | IDS-iSYS Ostase BAP | CIN | Substantially Equivalent | Immunodiagnostic Systems , Ltd. | accessdata.fda.gov |
| June 17, 2019 | K190121 | IDS SHBG | CDZ | Substantially Equivalent | Immunodiagnostic Systems , Ltd. | accessdata.fda.gov |
| January 31, 2017 | K161158 | IDS-iSYS Intact PTHN | CEW | Substantially Equivalent | Immunodiagnostic Systems , Ltd. | accessdata.fda.gov |
| November 15, 2016 | K161831 | IDS-iSYS 25VitDs, IDS-iSYS 25VitDs Control Set | MRG | Substantially Equivalent | Immunodiagnostic Systems , Ltd. | accessdata.fda.gov |
| May 17, 2016 | K161082 | IDS-iSYS 17-OH Progesterone Control Set, IDS-iSYS 17-OH Progesterone Calibration Verifiers | JJX | Substantially Equivalent | Immunodiagnostic Systems , Ltd. | accessdata.fda.gov |
| August 25, 2015 | K142351 | 25-Hydroxy Vitamin Ds EIA | MRG | Substantially Equivalent | Immunodiagnostic Systems , Ltd. | accessdata.fda.gov |
| April 21, 2015 | K142994 | IDS-iSYS Aldosterone,IDS iSYS Aldosterone Control Set, and IDS iSYS Aldosterone Calibration Verifiers | CJM | Substantially Equivalent | Immunodiagnostic Systems , Ltd. | accessdata.fda.gov |
| December 19, 2014 | K140554 | IDS-ISYS 25-HYDROXY VITAMIN DS, AND IDS-ISYS 25 HYDROXY VITAMIN DS CONTROL SET | MRG | Substantially Equivalent | Immunodiagnostic Systems , Ltd. | accessdata.fda.gov |
| December 24, 2013 | K123763 | IDS ISYS DIRECT RENIN ASSAY, IDS ISYS DIRECT RENIN CONTROL SET, AND IDS ISYS DIRECT RENIN CALIBRATION VERIFIERS | CIB | Substantially Equivalent | Immunodiagnostic Systems , Ltd. | accessdata.fda.gov |
| June 18, 2013 | K123253 | IDS ISYS 1,25 DIHYDROXY VITAMIN D, IDS-ISYS, 1,25 DIHYDROXY VITAMIN D CONTROL SET, AND IDS ISYS 1,25 DIHYDROXY VITAMIN D | MRG | Substantially Equivalent | Immunodiagnostic Systems , Ltd. | accessdata.fda.gov |
| August 7, 2012 | K122141 | IDS-ISYS IGF-I CALIBRATION VERIFIERS | JJX | Substantially Equivalent | Immunodiagnostic Systems , Ltd. | accessdata.fda.gov |
| February 14, 2012 | K111938 | IDS-ISYS IGFBP-3 CONTROL SET, IDS-ISYS HUMAN GROWTH HORMONE (HGH) CALIBRATION VERIFIERS, AND IDS-ISYS IGFBP-3 CAL... | JJX | Substantially Equivalent | Immunodiagnostic Systems , Ltd. | accessdata.fda.gov |
| February 3, 2012 | K103325 | IDS-ISYS INTACT PTH | CEW | Substantially Equivalent | Immunodiagnostic Systems , Ltd. | accessdata.fda.gov |
| September 6, 2011 | K111650 | IDS-ISYS CTX-1 (CROSSLAPS) CALIBRATION VERIFIERS, IDS-ISYS 25 HYDROXY VITAMIN D CALIBRATION VERIFIERS, AND IDS-ISYS... | JJX | Substantially Equivalent | Immunodiagnostic Systems , Ltd. | accessdata.fda.gov |
| March 16, 2011 | K110412 | IDS-ISYS IFG-I CONTROL SET | JJX | Substantially Equivalent | Immunodiagnostic Systems , Ltd. | accessdata.fda.gov |
| June 25, 2010 | K091849 | IDS-ISYS 25-HYDROXY VITAMIN D ASSAY, IDS-ISYS 25-HYDROXY VITAMIN D CONTROL SET | MRG | Substantially Equivalent | Immunodiagnostic Systems, Inc. | accessdata.fda.gov |
| July 6, 2005 | K051110 | 1,25-DIHYDROXY VITAMIN D EIA | MRG | Substantially Equivalent | Immunodiagnostic Systems , Ltd. | accessdata.fda.gov |
| December 1, 2004 | K042519 | GAMMA-B 1,25-DIHYDROXY VITAMIN D | MRG | Substantially Equivalent | Immunodiagnostic Systems , Ltd. | accessdata.fda.gov |
| May 16, 2001 | K003609 | N-MID OSTEOCALCIN ONE STEP ELISA MODEL 30SC4000 | NEO | Substantially Equivalent | Osteometer Biotech A/S | accessdata.fda.gov |
| September 17, 1999 | K991998 | GAMMA-B 25-HYDROXY VITAMIN D RIA | MRG | Substantially Equivalent | Immunodiagnostic Systems , Ltd. | accessdata.fda.gov |
| July 9, 1999 | K990843 | SERUM CROSSLAPS ONE STEP ELISA | JMM | Substantially Equivalent | Osteometer Biotech A/S | accessdata.fda.gov |
| September 11, 1997 | K972666 | TANDEM-MP OSTASE IMMUNOENZYMETRIC ASSAY | CIN | Substantially Equivalent | Hybritech, Inc. | accessdata.fda.gov |
Recalls
Recall events where this establishment is the recalling firm, matched on its FEI.
| Initiated | Event | Class | Status | Product | Reason | Source |
|---|---|---|---|---|---|---|
| August 10, 2012 | 62968 | Class II | Terminated | IDS Urine BETA CrossLaps ELISA, Catalog Number AC-05F1. Type of packaging: Cardboard Box containing plastic bottles. The Urine BETA CrossLaps ELISA is an enzyme immunological test for the quantification of degradation pr | 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. | accessdata.fda.gov |
Compare with other makers
- All makers of Immunoassay, Insulin-Like Growth Factor Binding Protein-1
- All makers of Single (Specified) Analyte Controls (Assayed And Unassayed)
- All makers of System, Test, Vitamin D
- All makers of Radioimmunoassay, Testosterones And Dihydrotestosterone
- All makers of Radioimmunoassay, Prolactin (Lactogen)
Updated August 21, 2026. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.