Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

8021924

FEI Number

3002485711

Entity Name

IMMUNODIAGNOSTIC SYSTEMS LTD.

City/State/Country

Boldon Colliery Durham, GB

Establishment Address

10 DIDCOT WAY, Boldon Colliery Durham NE35 9PD, GB

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

IMMUNODIAGNOSTIC SYSTEMS LTD. (Owner Number: 8021924)

Owner / Operator Contact Address

10 DIDCOT WAY, BOLDON BUSINESS PARK, BOLDON COLLIERY, GB-NOTA NE35 9PD, GB

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K111938

PMA Number

N/A

All Registered Proprietary Names

N-MID® Osteocalcin ELISA IDS Cortisol 1,25-Dihydroxy Vitamin D EIA IDS-iSYS Cartridge Check System (CCS) IDS-iSYS Cuvettes IDS-iSYS Wash Solution (Wash S) IDS-iSYS System Liquid (Syst l) IDS-iSYS Trigger Set IDS Immunocleaner IDS-iSYS D-Sorb Solution IDS-iSYS Insulin-like Growth Factor-I IGF-I Calibration Verifiers IDS-iSYS Total Testosterone Calibration Verifiers IDS-iSYS Ostase® BAP Calibration Verifiers IDS Beta CrossLaps (CTX-I) Control Set IDS SHBG Calibration Verifiers IDS-iSYS Ostase® BAP Control Set IDS Prolactin Calibrator Set IDS Beta CrossLaps (CTX-I) Calibrator Set IDS Cortisol Control Set IDS Cortisol Calibrator Set IDS-iSYS Free Testosterone Calibration Verifiers IDS-iSYS Free Testosterone Control Set IDS Androstenedione Calibrator Set IDS-iSYS 25 VitDS Calibrator Set IDS Androstenedione Control Set IDS ACTH II Calibrator Set IDS SHBG Control Set IDS-iSYS Total Testosterone Control Set IDS ACTH II Control Set IDS Prolactin IDS-iSYS Ostase® BAP 1,25-Dihydroxy Vitamin D RIA IDS-iSYS 25 VitDS Control Set IDS-iSYS 25 VitDS IDS-iSYS Diluent B IDS-iSYS Diluent C IDS-iSYS Diluent A IDS-iSYS Total Testosterone Serum CrossLaps® (CTX-I) ELISA IDS-iSYS CTX-I (Crosslaps) Control Set Ostase® BAP EIA IDS ACTH II IDS-iSYS Aldosterone Control Set IDS-iSYS Aldosterone IDS-iSYS Aldosterone Calibration Verifiers IDS-iSYS XPrep IDS-iSYS Insulin like Growth FactorI (IGF-I) Control Set IDS-iSYS Human Growth Hormone (hGH) IDS-iSYS Insulin-like Growth Factor Binding Protein 3 (IGFBP-3) IGF-I ELISA IDS iSYS 1,25 Dihydroxy Vitamin D Control Set IDS iSYS 1,25 Dihydroxy Vitamin D Calibration Verifiers IDS iSYS 1,25 Dihydroxy Vitamin D 25-Hydroxy Vitamin D RIA IDS-iSYS Human Growth Hormone (hGH) Calibration Verifiers IDS-iSYS Insulin-like Growth Factor Binding Protein 3 (IGFBP-3) Control Set IDS-iSYS Insulin-like Growth Factor Binding Protein-3 (IGFBP-3) Calibration Verifiers

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
NEO	System, Test, Osteocalcin	Clinical Chemistry	Class 2	862.1050	2008-09-17
CGR	Radioimmunoassay, Cortisol	Clinical Chemistry	Class 2	862.1205	2021-04-13
MRG	System, Test, Vitamin D	Clinical Chemistry	Class 2	862.1825	2007-10-26
JJE	Analyzer, Chemistry (Photometric, Discrete), For Clinical Use	Clinical Chemistry	Class 1	862.2160	2009-12-02
JJX	Single (Specified) Analyte Controls (Assayed And Unassayed)	Clinical Chemistry	Class 1	862.1660	2012-08-09
JJX	Single (Specified) Analyte Controls (Assayed And Unassayed)	Clinical Chemistry	Class 1	862.1660	2019-08-08
CFT	Radioimmunoassay, Prolactin (Lactogen)	Clinical Chemistry	Class 1	862.1625	2024-02-23
CIN	Electrophoretic Separation, Alkaline Phosphatase Isoenzymes	Clinical Chemistry	Class 2	862.1050	2020-10-05
MRG	System, Test, Vitamin D	Clinical Chemistry	Class 2	862.1825	2007-10-26
MRG	System, Test, Vitamin D	Clinical Chemistry	Class 2	862.1825	2016-12-08
JJX	Single (Specified) Analyte Controls (Assayed And Unassayed)	Clinical Chemistry	Class 1	862.1660	2016-12-08
LXG	Equipment, Laboratory, General Purpose, Labeled Or Promoted For A Specific Medical Use	Clinical Chemistry	Class 1	862.2050	2014-01-30
CDZ	Radioimmunoassay, Testosterones And Dihydrotestosterone	Clinical Chemistry	Class 1	862.1680	2026-04-16
JMM	Column Chromatography & Color Development, Hydroxyproline	Clinical Chemistry	Class 1	862.1400	2008-09-17
JJX	Single (Specified) Analyte Controls (Assayed And Unassayed)	Clinical Chemistry	Class 1	862.1660	2011-09-12
CIN	Electrophoretic Separation, Alkaline Phosphatase Isoenzymes	Clinical Chemistry	Class 2	862.1050	2007-10-26
CKG	Radioimmunoassay, Acth	Clinical Chemistry	Class 2	862.1025	2023-08-22
JJX	Single (Specified) Analyte Controls (Assayed And Unassayed)	Clinical Chemistry	Class 1	862.1660	2015-04-21
CJM	Radioimmunoassay, Aldosterone	Clinical Chemistry	Class 2	862.1045	2015-04-21
JRQ	Shaker/Stirrer	Clinical Chemistry	Class 1	862.2050	2022-01-07
JJX	Single (Specified) Analyte Controls (Assayed And Unassayed)	Clinical Chemistry	Class 1	862.1660	2011-04-12
CFL	Radioimmunoassay, Human Growth Hormone	Clinical Chemistry	Class 1	862.1370	2000-12-08
JJX	Single (Specified) Analyte Controls (Assayed And Unassayed)	Clinical Chemistry	Class 1	862.1660	2013-06-24
MRG	System, Test, Vitamin D	Clinical Chemistry	Class 2	862.1825	2013-06-24
MRG	System, Test, Vitamin D	Clinical Chemistry	Class 2	862.1825	2007-10-26
JJX	Single (Specified) Analyte Controls (Assayed And Unassayed)	Clinical Chemistry	Class 1	862.1660	2012-02-17

Official Correspondent

No official correspondent registered.

US Agent Details

Faith Du Business: Euroimmun US Inc. Email: ra-us@euroimmun.us Phone: (800) 9132022

Related Public Records

Same Entity

IMMUNODIAGNOSTIC SYSTEMS LTD.

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Other Registrations for Same Entity

Registration Number	Establishment Name	Location
3007500635	Immunodiagnostic Systems SA	Liege, BE
9615777	IMMUNODIAGNOSTIC SYSTEMS FRANCE SAS	POUILLY EN AUXOIS Cote-d'Or, FR

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K821068	Diagnostic Systems Laboratories, Inc.	DSL 1020	1982-05-05
K821931	Amf Biological and Diagnostics Co.	ZETA-CORT	1982-07-22
K200509	Siemens Healthcare Diagnostics, Inc.	ADVIA Centaur Vitamin D Total (VitD)	2020-05-29
K872302	Ciba Corning Diagnostics Corp.	MODEL 550 EXPRESS CLINICAL CHEMISTRY ANALYZER	1987-09-08
K103744	Quantimetrix Corp.	DROPPER A1C DIABETES CONTROL	2011-05-12

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0039-2013	Immunodiagnostics Systems Ltd 10 Didcot Way Bolden Business Park Boldon Tyne & Wear United Kingdom	1	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
Z-0040-2013	Immunodiagnostics Systems Ltd 10 Didcot Way Bolden Business Park Boldon Tyne & Wear United Kingdom	2	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.
Z-0041-2013	Immunodiagnostics Systems Ltd 10 Didcot Way Bolden Business Park Boldon Tyne & Wear United Kingdom	2	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.
Z-0042-2013	Immunodiagnostics Systems Ltd 10 Didcot Way Bolden Business Park Boldon Tyne & Wear United Kingdom	2	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.
Z-0043-2013	Immunodiagnostics Systems Ltd 10 Didcot Way Bolden Business Park Boldon Tyne & Wear United Kingdom	2	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.
Z-0044-2013	Immunodiagnostics Systems Ltd 10 Didcot Way Bolden Business Park Boldon Tyne & Wear United Kingdom	2	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.

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 8021924. Last updated year: 2026. Please use registration number 8021924 when referencing this establishment in official correspondence.