Company ยท GB
Immunodiagnostic Systems , Ltd.
FDA 510(k) clearances and medical device recalls filed under this name, 1994 to 2026. Name variants (Inc, Corp, punctuation) are merged.
27510(k) clearances (1 in 12 months)
0recalls (0 in 12 months)
0recalls that name a 510(k)
Product codes
| Code | Device | Records |
|---|---|---|
| MRG | System, Test, Vitamin D | 9 |
| JJX | Single (Specified) Analyte Controls (Assayed And Unassayed) | 6 |
| CDZ | Radioimmunoassay, Testosterones And Dihydrotestosterone | 3 |
| CEW | Radioimmunoassay, Parathyroid Hormone | 3 |
| CFL | Radioimmunoassay, Human Growth Hormone | 1 |
| CGR | Radioimmunoassay, Cortisol | 1 |
| CIB | Radioimmunoassay, Angiotensin I And Renin | 1 |
| CIN | Electrophoretic Separation, Alkaline Phosphatase Isoenzymes | 1 |
| CJM | Radioimmunoassay, Aldosterone | 1 |
| CKG | Radioimmunoassay, Acth | 1 |
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Apr 15, 2026 | K252728 | IDS-iSYS Total Testosterone Immunodiagnostic Systems Limited, GB | CDZ |
| Oct 23, 2024 | K240865 | IDS-iSYS Free Testosterone Immunodiagnostic Systems Limited, GB | CDZ |
| Aug 18, 2023 | K223867 | IDS ACTH II Immunodiagnostic Systems Limited, GB | CKG |
| Apr 13, 2021 | K202136 | IDS Cortisol Immunodiagnostic Systems , Ltd., GB | CGR |
| Sep 30, 2020 | K200475 | IDS-iSYS Ostase BAP Immunodiagnostic Systems , Ltd., GB | CIN |
| Jun 17, 2019 | K190121 | IDS SHBG Immunodiagnostic Systems , Ltd., GB | CDZ |
| Jan 31, 2017 | K161158 | IDS-iSYS Intact PTHN Immunodiagnostic Systems , Ltd., GB | CEW |
| Nov 15, 2016 | K161831 | IDS-iSYS 25VitDs, IDS-iSYS 25VitDs Control Set Immunodiagnostic Systems , Ltd., GB | MRG |
| May 17, 2016 | K161082 | IDS-iSYS 17-OH Progesterone Control Set, IDS-iSYS 17-OH Progesterone Calibration Verifiers Immunodiagnostic Systems , Ltd., GB | JJX |
| Aug 25, 2015 | K142351 | 25-Hydroxy Vitamin Ds EIA Immunodiagnostic Systems , Ltd., GB | MRG |
| Apr 21, 2015 | K142994 | IDS-iSYS Aldosterone,IDS iSYS Aldosterone Control Set, and IDS iSYS Aldosterone Calibration Verifiers Immunodiagnostic Systems , Ltd., GB | CJM |
| Mar 30, 2015 | K143324 | IDS-iSYS CTX-I Calibration Verifiers Immunodiagnostic Systems , Ltd., GB | JJX |
| Dec 19, 2014 | K140554 | IDS-ISYS 25-HYDROXY VITAMIN DS, AND IDS-ISYS 25 HYDROXY VITAMIN DS CONTROL SET Immunodiagnostic Systems , Ltd., GB | MRG |
| Dec 24, 2013 | K123763 | IDS ISYS DIRECT RENIN ASSAY, IDS ISYS DIRECT RENIN CONTROL SET, AND IDS ISYS DIRECT RENIN CALIBRATION VERIFIERS Immunodiagnostic Systems , Ltd., GB | CIB |
| Jun 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 Immunodiagnostic Systems , Ltd., GB | MRG |
| Aug 7, 2012 | K122141 | IDS-ISYS IGF-I CALIBRATION VERIFIERS Immunodiagnostic Systems , Ltd., GB | JJX |
| Feb 14, 2012 | K111938 | IDS-ISYS IGFBP-3 CONTROL SET, IDS-ISYS HUMAN GROWTH HORMONE (HGH) CALIBRATION VERIFIERS, AND IDS-ISYS IGFBP-3 CAL... Immunodiagnostic Systems , Ltd., GB | JJX |
| Feb 3, 2012 | K103325 | IDS-ISYS INTACT PTH Immunodiagnostic Systems , Ltd., GB | CEW |
| Sep 6, 2011 | K111650 | IDS-ISYS CTX-1 (CROSSLAPS) CALIBRATION VERIFIERS, IDS-ISYS 25 HYDROXY VITAMIN D CALIBRATION VERIFIERS, AND IDS-ISYS... Immunodiagnostic Systems , Ltd., GB | JJX |
| Mar 16, 2011 | K110412 | IDS-ISYS IFG-I CONTROL SET Immunodiagnostic Systems , Ltd., GB | JJX |
| Jun 25, 2010 | K091849 | IDS-ISYS 25-HYDROXY VITAMIN D ASSAY, IDS-ISYS 25-HYDROXY VITAMIN D CONTROL SET Immunodiagnostic Systems, Inc. | MRG |
| Jul 6, 2005 | K051110 | 1,25-DIHYDROXY VITAMIN D EIA Immunodiagnostic Systems , Ltd., GB | MRG |
| Dec 1, 2004 | K042519 | GAMMA-B 1,25-DIHYDROXY VITAMIN D Immunodiagnostic Systems , Ltd., GB | MRG |
| May 10, 2002 | K021163 | OCTEIA 25-HYDROXY VITAMIN D Immunodiagnostic Systems , Ltd., GB | MRG |
| Sep 17, 1999 | K991998 | GAMMA-B 25-HYDROXY VITAMIN D RIA Immunodiagnostic Systems , Ltd., GB | MRG |
| Apr 5, 1995 | K950510 | OCTEIA IGF-1 KIT Immunodiagnostic Systems , Ltd., GB | CFL |
| Sep 20, 1994 | K942369 | GAMMA-BCT INTACT PTH Immunodiagnostic Systems , Ltd., GB | CEW |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| No recalls in this window. | |||