IMMUNODIAGNOSTIC SYSTEMS LTD.

Registration Details

Registration Name: IMMUNODIAGNOSTIC SYSTEMS LTD.
Registration Number: 8021924
FEI Number: 3002485711
Status: Active
Expiry Year: 2026
Initial Importer: No
Address: 10 DIDCOT WAY
City: Boldon Colliery Durham
Country: GB

Regulatory Submissions

510(k) Number: K003609

Owner / Operator

Firm Name: IMMUNODIAGNOSTIC SYSTEMS LTD.
Operator Number: 8021924
Address: 10 DIDCOT WAY, BOLDON BUSINESS PARK
City: BOLDON COLLIERY
State: GB-NOTA
Postal Code: NE35 9PD
Country: GB

US Agent

Business Name: Euroimmun US Inc.
Contact Name: Faith Du
Address: 1 Bloomfield Avenue
City: Mountain Lakes
State: NJ
ZIP: 07046
Country: US
Email: [email protected]
Phone: 800 9132022 ext. 118

Products

Device Name	Product Code	Device Class	Medical Specialty	Exempt	Created
System, Test, Osteocalcin	NEO	Class 2	Clinical Chemistry	No	2008-09-17
Radioimmunoassay, Cortisol	CGR	Class 2	Clinical Chemistry	No	2021-04-13
System, Test, Vitamin D	MRG	Class 2	Clinical Chemistry	No	2007-10-26
Analyzer, Chemistry (Photometric, Discrete), For Clinical Use	JJE	Class 1	Clinical Chemistry	No	2009-12-02
Single (Specified) Analyte Controls (Assayed And Unassayed)	JJX	Class 1	Clinical Chemistry	No	2012-08-09
Radioimmunoassay, Prolactin (Lactogen)	CFT	Class 1	Clinical Chemistry	No	2024-02-23
Electrophoretic Separation, Alkaline Phosphatase Isoenzymes	CIN	Class 2	Clinical Chemistry	No	2020-10-05
Equipment, Laboratory, General Purpose, Labeled Or Promoted For A Specific Medical Use	LXG	Class 1	Clinical Chemistry	No	2014-01-30
Radioimmunoassay, Testosterones And Dihydrotestosterone	CDZ	Class 1	Clinical Chemistry	No	2026-04-16
Column Chromatography & Color Development, Hydroxyproline	JMM	Class 1	Clinical Chemistry	No	2008-09-17
Radioimmunoassay, Acth	CKG	Class 2	Clinical Chemistry	No	2023-08-22
Radioimmunoassay, Aldosterone	CJM	Class 2	Clinical Chemistry	No	2015-04-21
Shaker/Stirrer	JRQ	Class 1	Clinical Chemistry	No	2022-01-07
Radioimmunoassay, Human Growth Hormone	CFL	Class 1	Clinical Chemistry	No	2000-12-08
Radioimmunoassay, Androstenedione	CIZ	Class 1	Clinical Chemistry	No	2022-12-15
Radioimmunoassay, Parathyroid Hormone	CEW	Class 2	Clinical Chemistry	No	2017-02-01
Calibrator, Secondary	JIT	Class 2	Clinical Chemistry	No	2012-02-13
Radioimmunoassay, Angiotensin I And Renin	CIB	Class 2	Clinical Chemistry	No	2013-12-31
Immunoassay, Insulin-Like Growth Factor Binding Protein-1	OAM	Class 1	Clinical Chemistry	No	2011-11-23
Radioimmunoassay, Progesterone	JLS	Class 1	Clinical Chemistry	No	2016-05-18

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 IDS-i10 IDS iSYS Multi Discipline Automated System IDS i20 25-Hydroxy Vitamin DS EIA IDS Androstenedione IDS Intact PTHN IDS-iSYS Free Testosterone IDS-iSYS 25-Hydroxy Vitamin DS Control Set IDS-iSYS 25-Hydroxy Vitamin DS Calibration Verifiers IDS-iSYS 25-Hydroxy Vitamin DS IDS-iSYS 17-OH Progesterone Control Set IDS-iSYS 17-OH Progesterone Calibration Verifiers IDS-iSYS Intact PTH Calibration Verifiers IDS-iSYS Intact PTH IDS-iSYS Intact PTH Control Set IDS-iSYS Direct Renin IDS-iSYS Direct Renin Control Set IDS-iSYS Direct Renin Calibration Verifiers IDS SDSpeed Calc IDS-iSYS Insulin like Growth Factor-I (IGF-I) IDS SHBG IDS-iSYS 17-OH Progesterone Alpha CrossLaps® (CTX-I) EIA Urine CrossLaps® (CTX-I) EIA Urine CartiLaps ® (CTX-II) EIA IDS-iSYS CTX-I (CrossLaps®) IDS Beta CrossLaps® (CTX-I) Urine BETA CrossLaps® (CTX-I) ELISA

Establishment Types

Manufacture Medical Device