Immunodiagnostic Systems Ltd.
Liege Liege, BE
IMMUNODIAGNOSTIC SYSTEMS LTD. appears in FDA device records in Liege Liege, BE. FDA records list 27 510(k) clearances between and , no PMA records and 2 registered establishments. As of , FDA records show 8 recalls for this company, and at least one establishment registration is current.
FDA records held for this company
FDA records under these names
1 nameFDA records resolved to Immunodiagnostic Systems Ltd. carry these names as well, as FDA wrote them. Each is the firm named on a registration, a 510(k), a PMA, a recall or an enforcement report that was joined to this company on a shared FDA identifier or on a matching name.
- Immunodiagnostics Systems Ltdenforcement report, recall
510(k) clearance history
FDA records hold 27 510(k) clearances for Immunodiagnostic Systems Ltd. between 1994 and 2026. The busiest year on record is 2012, with 3. The most recent is 2026, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 1994 | 1 |
| 1995 | 1 |
| 1999 | 1 |
| 2002 | 1 |
| 2004 | 1 |
| 2005 | 1 |
| 2010 | 1 |
| 2011 | 2 |
| 2012 | 3 |
| 2013 | 2 |
| 2014 | 1 |
| 2015 | 3 |
| 2016 | 2 |
| 2017 | 1 |
| 2019 | 1 |
| 2020 | 1 |
| 2021 | 1 |
| 2023 | 1 |
| 2024 | 1 |
| 2026 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K252728 | IDS-iSYS Total Testosterone | CDZ | Substantially Equivalent | |
| K240865 | IDS-iSYS Free Testosterone | CDZ | Substantially Equivalent | |
| K223867 | IDS ACTH II | CKG | Substantially Equivalent | |
| K202136 | IDS Cortisol | CGR | Substantially Equivalent | |
| K200475 | IDS-iSYS Ostase BAP | CIN | Substantially Equivalent | |
| K190121 | IDS SHBG | CDZ | Substantially Equivalent | |
| K161158 | IDS-iSYS Intact PTHN | CEW | Substantially Equivalent | |
| K161831 | IDS-iSYS 25VitDs, IDS-iSYS 25VitDs Control Set | MRG | Substantially Equivalent | |
| K161082 | IDS-iSYS 17-OH Progesterone Control Set, IDS-iSYS 17-OH Progesterone Calibration Verifiers | JJX | Substantially Equivalent | |
| K142351 | 25-Hydroxy Vitamin Ds EIA | MRG | Substantially Equivalent | |
| K142994 | IDS-iSYS Aldosterone,IDS iSYS Aldosterone Control Set, and IDS iSYS Aldosterone Calibration Verifiers | CJM | Substantially Equivalent | |
| K143324 | IDS-iSYS CTX-I Calibration Verifiers | JJX | Substantially Equivalent | |
| K140554 | IDS-ISYS 25-HYDROXY VITAMIN DS, AND IDS-ISYS 25 HYDROXY VITAMIN DS CONTROL SET | MRG | Substantially Equivalent | |
| K123763 | IDS ISYS DIRECT RENIN ASSAY, IDS ISYS DIRECT RENIN CONTROL SET, AND IDS ISYS DIRECT RENIN CALIBRATION VERIFIERS | CIB | Substantially Equivalent | |
| 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 | |
| K122141 | IDS-ISYS IGF-I CALIBRATION VERIFIERS | JJX | Substantially Equivalent | |
| K111938 | IDS-ISYS IGFBP-3 CONTROL SET, IDS-ISYS HUMAN GROWTH HORMONE (HGH) CALIBRATION VERIFIERS, AND IDS-ISYS IGFBP-3 CAL... | JJX | Substantially Equivalent | |
| K103325 | IDS-ISYS INTACT PTH | CEW | Substantially Equivalent | |
| K111650 | IDS-ISYS CTX-1 (CROSSLAPS) CALIBRATION VERIFIERS, IDS-ISYS 25 HYDROXY VITAMIN D CALIBRATION VERIFIERS, AND IDS-ISYS... | JJX | Substantially Equivalent | |
| K110412 | IDS-ISYS IFG-I CONTROL SET | JJX | Substantially Equivalent | |
| K091849 | IDS-ISYS 25-HYDROXY VITAMIN D ASSAY, IDS-ISYS 25-HYDROXY VITAMIN D CONTROL SET | MRG | Substantially Equivalent | |
| K051110 | 1,25-DIHYDROXY VITAMIN D EIA | MRG | Substantially Equivalent | |
| K042519 | GAMMA-B 1,25-DIHYDROXY VITAMIN D | MRG | Substantially Equivalent | |
| K021163 | OCTEIA 25-HYDROXY VITAMIN D | MRG | Substantially Equivalent | |
| K991998 | GAMMA-B 25-HYDROXY VITAMIN D RIA | MRG | Substantially Equivalent | |
| K950510 | OCTEIA IGF-1 KIT | CFL | Substantially Equivalent | |
| K942369 | GAMMA-BCT INTACT PTH | CEW | Substantially Equivalent |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 8021924 | 3002485711 | IMMUNODIAGNOSTIC SYSTEMS LTD. | 10 DIDCOT WAY, Boldon Colliery Durham NE35 9PD GB | 2026 | and 14 more, listed in full below |
| 3007500635 | 3007500635 | Immunodiagnostic Systems SA | Rue Ernest Solvay 101, Liege 4000 BE | 2026 |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
- JJEAnalyzer, Chemistry (Photometric, Discrete), For Clinical Use
- JITCalibrator, Secondary
- JMMColumn Chromatography & Color Development, Hydroxyproline
- CINElectrophoretic Separation, Alkaline Phosphatase Isoenzymes
- LXGEquipment, Laboratory, General Purpose, Labeled Or Promoted For A Specific Medical Use
- OAMImmunoassay, Insulin-Like Growth Factor Binding Protein-1
- CKGRadioimmunoassay, Acth
- CJMRadioimmunoassay, Aldosterone
- CIZRadioimmunoassay, Androstenedione
- CIBRadioimmunoassay, Angiotensin I And Renin
- CGRRadioimmunoassay, Cortisol
- CHPRadioimmunoassay, Estradiol
- CFLRadioimmunoassay, Human Growth Hormone
- CEWRadioimmunoassay, Parathyroid Hormone
- JLSRadioimmunoassay, Progesterone
- CFTRadioimmunoassay, Prolactin (Lactogen)
- CDZRadioimmunoassay, Testosterones And Dihydrotestosterone
- JRQShaker/Stirrer
- JJXSingle (Specified) Analyte Controls (Assayed And Unassayed)
- NEOSystem, Test, Osteocalcin
- MRGSystem, Test, Vitamin D
Recall records
| Recall | Product | Reason | Classification | Initiated | Status |
|---|---|---|---|---|---|
| Z-0045-2013 | IDS-iSYS Intact PINP Control Set, Catalog Number IS-4030. Packaged in cardboard Box containing plastic bottles. The IDS-iSYS Intact amino-terminal propeptide of type I procollagen (Intact PINP) Control Set is used for quality control of the IDS-iSYS Intact PINP Assay on the IDS-iSYS Multi-Discipline Automated Analyser. | 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. | Class II | Terminated | |
| Z-0044-2013 | IDS-iSYS Intact PINP, Catalog Number IS-4000. Packaged in cardboard Box containing plastic bottles. The IDS-iSYS Intact amino-terminal propeptide of type I procollagen (Intact PINP) assay is intended for the quantitative determination of intact PINP in human serum or plasma on the IDS-iSYS Multi-Discipline Automated Analyser. | 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. | Class II | Terminated | |
| Z-0043-2013 | IDS-iSYS N-Mid Osteocalcin, Catalog Number IS-2930. Packaged in cardboard Box containing plastic bottles. The IDS-iSYS N-Mid Osteocalcin Control Set is used for quality control of the IDS-iSYS N-Mid Osteocalcin Assay on the IDS-iSYS Multi-Discipline Automated Analyser. | 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. | Class II | Terminated | |
| Z-0042-2013 | IDS-iSYS N-Mid Osteocalcin, Catalog Number IS-2900. Packaged in cardboard Box containing plastic bottles. The IDS-iSYS N-Mid Osteocalcin Assay is intended for the quantitative determination of Osteocalcin in human serum or plasma on the IDS-iSYS Multi-Discipline Automated Analyser (Analyser). Results are to be used in conjunction with other clinical and laboratory data to assist the clinician. Osteocalcin is an indicator of osteoblastic activity in human serum and plasma and is intended to be used as an aid in the prevention of osteoporosis. | 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. | Class II | Terminated | |
| Z-0041-2013 | IDS-iSYS Ostase BAP (Bone Alkaline Phosphatase) Control Set, Catalog Number IS-2830. Packaged in cardboard Box containing plastic bottles. The IDS-iSYS Ostase BAP (IDS-iSYS BAP) Control Set is used for quality control of the IDS-iSYS Ostase BAP (Bone Alkaline Phosphatase) Assay on the IDS-iSYS Multi-Discipline Automated Analyser. | 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. | Class II | Terminated | |
| Z-0040-2013 | IDS-iSYS Ostase BAP (Bone Alkaline Phosphatase), Catalog Number IS-2800. Packaged in cardboard Box containing plastic bottles. The IDS-iSYS Ostase BAP Assay (IDS-iSYS BAP) is intended for the quantitative determination of bone-specific alkaline phosphatase (BAP), an indicator of osteoblastic activity, in human serum or plasma on the IDS-iSYS Multi- Discipline Automated Analyser (Analyser). Results are to be used in conjunction with other clinical and laboratory data to aid the clinician in the management of post menopausal osteoporosis and Pagets disease. | 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. | Class II | Terminated | |
| Z-0039-2013 | 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 products of C-terminal telopeptides of Type-I collagen in human urine. The Urine BETA CrossLaps ELISA assay is intended for in vitro diagnostic use as an indication of human bone resorption as an aid in A. Monitoring bone resorption changes of 1) Anti-resorptive therapies in postmenopausal women: a) Hormone Replacement Therapies (HRT) with hormones and hormone like drugs b) Bisphosphonate therapies B. Predicting skeletal response (Bone Mineral Density) in postmenopausal women undergoing anti-resorptive therapies a) Hormone Replacement Therapies (HRT) with hormones and hormone like drugs b) Bisphosphonate therapies | 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. | Class II | Terminated | |
| Z-0173-2009 | IDS 25-Hydroxy Vitamin D EIA Enzymeimmunoassay for the quantitative determination of 25-hydroxyvitamin D and other hydroxylated metabolites in serum or plasma. Ref: AC-57F1 Lot 60897 Exp 2009-08; Immunodiagnostic Systems Ltd, Unit 10, Boldon Business Park, Boldon, Tyne & Wear, NE35. 9PD, UK. Enzymeimmunoassay for the quantitative determination of 25-hydroxyvitamin D and other hydroxylated metabolites in serum or plasma | A small number of customers have experienced low absorbance values when using kits from this batch. | Terminated |
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Data as of , FDA export datePage updated Source: openFDA, public domain