Immunodiagnostic Systems , Ltd.
Medical device manufacturer in Tyne & Wear, GB.
27510(k) clearances
0PMA approvals
0recalls
Device types
- MRG System, Test, Vitamin D 9
- JJX Single (Specified) Analyte Controls… 6
- CEW Radioimmunoassay, Parathyroid Hormone 3
- CDZ Radioimmunoassay, Testosterones And… 3
- CFL Radioimmunoassay, Human Growth Hormone 1
- CIB Radioimmunoassay, Angiotensin I And Renin 1
- CJM Radioimmunoassay, Aldosterone 1
- CIN Electrophoretic Separation, Alkaline… 1
- CGR Radioimmunoassay, Cortisol 1
- CKG Radioimmunoassay, Acth 1
510(k) clearances
| 510(k) | Device | Decision |
|---|---|---|
| K252728 | IDS-iSYS Total TestosteroneCDZ · Traditional | 04/15/2026SE |
| K240865 | IDS-iSYS Free TestosteroneCDZ · Traditional | 10/23/2024SE |
| K223867 | Ids Acth IICKG · Traditional | 08/18/2023SE |
| K202136 | IDS CortisolCGR · Traditional | 04/13/2021SE |
| K200475 | IDS-iSYS Ostase BAPCIN · Traditional | 09/30/2020SE |
| K190121 | Ids SHBGCDZ · Traditional | 06/17/2019SE |
| K161158 | IDS-iSYS Intact PTHNCEW · Traditional | 01/31/2017SE |
| K161831 | IDS-iSYS 25VitDs, IDS-iSYS 25VitDs Control SetMRG · Traditional | 11/15/2016SE |
| K161082 | IDS-iSYS 17-OH Progesterone Control Set, IDS-iSYS 17-OH Progesterone Calibration VerifiersJJX · Traditional | 05/17/2016SE |
| K142351 | 25-Hydroxy Vitamin Ds EIAMRG · Traditional | 08/25/2015SE |
| K142994 | IDS-iSYS Aldosterone,IDS iSYS Aldosterone Control Set, and IDS iSYS Aldosterone…CJM · Traditional | 04/21/2015SE |
| K143324 | IDS-iSYS CTX-I Calibration VerifiersJJX · Traditional | 03/30/2015SE |
| K140554 | Ids-Isys 25-HYDROXY Vitamin DS, and Ids-Isys 25 Hydroxy Vitamin DS Control SetMRG · Traditional | 12/19/2014SE |
| K123763 | Ids Isys Direct Renin Assay, Ids Isys Direct Renin Control Set, and Ids Isys Direct…CIB · Traditional | 12/24/2013SE |
| K123253 | Ids Isys 1,25 Dihydroxy Vitamin D, Ids-Isys, 1,25 Dihydroxy Vitamin D Control Set, and…MRG · Traditional | 06/18/2013SE |
| K122141 | Ids-Isys Igf-I Calibration VerifiersJJX · Abbreviated | 08/07/2012SE |
| K111938 | Ids-Isys IGFBP-3 Control Set, Ids-Isys Human Growth Hormone (HGH) Calibration Verifiers…JJX · Abbreviated | 02/14/2012SE |
| K103325 | Ids-Isys Intact PTHCEW · Traditional | 02/03/2012SE |
| K111650 | Ids-Isys CTX-1 (Crosslaps) Calibration Verifiers, Ids-Isys 25 Hydroxy Vitamin D…JJX · Abbreviated | 09/06/2011SE |
| K110412 | Ids-Isys Ifg-I Control SetJJX · Abbreviated | 03/16/2011SE |
| K091849 | Ids-Isys 25-HYDROXY Vitamin D Assay, Ids-Isys 25-HYDROXY Vitamin D Control SetMRG · Traditional | 06/25/2010SE |
| K051110 | 1,25-DIHYDROXY Vitamin D EiaMRG · Abbreviated | 07/06/2005SE |
| K042519 | Gamma-B 1,25-DIHYDROXY Vitamin DMRG · Abbreviated | 12/01/2004SE |
| K021163 | Octeia 25-HYDROXY Vitamin DMRG · Traditional | 05/10/2002SE |
| K991998 | Gamma-B 25-HYDROXY Vitamin D RiaMRG · Traditional | 09/17/1999SE |
| K950510 | Octeia IGF-1 KitCFL · Traditional | 04/05/1995SE |
| K942369 | Gamma-Bct Intact PTHCEW · Traditional | 09/20/1994SE |