Immunodiagnostic Systems S A

FDA Filings

This page includes the latest FDA filings for Immunodiagnostic Systems S A. Currently, you will find the latest 100 filings for Premarket Notifications, Premarket Applications, De Novo Applications, and GUDID registrations.

FDA Registration(s)

• Registration Number: 3007500635
• FEI Number: 3007500635
• Name: Immunodiagnostic Systems SA
• Owner & Operator: IMMUNODIAGNOSTIC SYSTEMS LTD.
• Contact Address: 10 DIDCOT WAY BOLDON BUSINESS PARK; BOLDON COLLIERY GB-NOTA NE35 9PD GB
• Official Correspondent:
  • Mick - Henderson
  • 44-191-5190660-x
• US Agent:
  • Susan Durham
  • Immunodiagnostic Systems Inc.
  • 877 8526210
  • 301 9904236
  • Susan.durham@idsplc.com
• Registration Status: 1
• Initial Importer: N
• Registration Expiration: 2020-04-25
• Registration Address: Rue Ernest Solvay 101 ; Liege Liege, 4000 BE
• Establishment Type:
  • Manufacture Medical Device
  • Manufacture Medical Device for Another Party (Contract Manufacturer)

FDA Filings

Device Company	Device	Date
GUDID 05425030426012 Immunodiagnostic Systems SA	IDS-iSYS Cartridge Check System (CCS)	2019-12-23
GUDID 05425030421024 Immunodiagnostic Systems SA	IDS-iSYS Trigger Set	2019-12-23
GUDID 05425030421031 Immunodiagnostic Systems SA	IDS-iSYS Wash Solution (Wash S)	2018-03-29
GUDID 05425030421017 Immunodiagnostic Systems SA	IDS-iSYS System Liquid (Syst. l)	2018-03-29
PMN K161158 | CEW Immunodiagnostic Systems SA [IMMUNODIAGNOSTIC SYSTEMS LTD.]	IDS-iSYS Intact PTHn	2017-02-01
PMN K161831 | MRG Immunodiagnostic Systems SA [IMMUNODIAGNOSTIC SYSTEMS LTD.]	IDS-iSYS 25 VitDS	2016-12-08
PMN K161831 | MRG Immunodiagnostic Systems SA [IMMUNODIAGNOSTIC SYSTEMS LTD.]	IDS-iSYS 25 VitDS Control Set	2016-12-08
PMN K161831 | JJX Immunodiagnostic Systems SA [IMMUNODIAGNOSTIC SYSTEMS LTD.]	IDS-iSYS 25 VitDS	2016-12-08
PMN K161831 | JJX Immunodiagnostic Systems SA [IMMUNODIAGNOSTIC SYSTEMS LTD.]	IDS-iSYS 25 VitDS Control Set	2016-12-08
PMN K161082 | JJX Immunodiagnostic Systems SA [IMMUNODIAGNOSTIC SYSTEMS LTD.]	IDS-iSYS 17-OH Progesterone Control Set IDS-iSYS 17-OH Progesterone Calibration Verifiers	2016-05-18
PMN K142994 | JJX Immunodiagnostic Systems SA [IMMUNODIAGNOSTIC SYSTEMS LTD.]	IDS-iSYS Aldosterone	2015-04-21
PMN K142994 | JJX Immunodiagnostic Systems SA [IMMUNODIAGNOSTIC SYSTEMS LTD.]	IDS-iSYS Aldosterone Control Set	2015-04-21
PMN K142994 | JJX Immunodiagnostic Systems SA [IMMUNODIAGNOSTIC SYSTEMS LTD.]	IDS-iSYS Aldosterone Calibration Veifiers	2015-04-21
PMN K142994 | CJM Immunodiagnostic Systems SA [IMMUNODIAGNOSTIC SYSTEMS LTD.]	IDS-iSYS Aldosterone	2015-04-21
PMN K142994 | CJM Immunodiagnostic Systems SA [IMMUNODIAGNOSTIC SYSTEMS LTD.]	IDS-iSYS Aldosterone Control Set	2015-04-21
PMN K142994 | CJM Immunodiagnostic Systems SA [IMMUNODIAGNOSTIC SYSTEMS LTD.]	IDS-iSYS Aldosterone Calibration Veifiers	2015-04-21
PMN K140554 | MRG Immunodiagnostic Systems SA [IMMUNODIAGNOSTIC SYSTEMS LTD.]	IDS-iSYS 25-Hydroxy Vitamin DS	2015-01-30
PMN K140554 | MRG Immunodiagnostic Systems SA [IMMUNODIAGNOSTIC SYSTEMS LTD.]	IDS-iSYS 25-Hydroxy Vitamin DS Control Set	2015-01-30
PMN K140554 | JJX Immunodiagnostic Systems SA [IMMUNODIAGNOSTIC SYSTEMS LTD.]	IDS-iSYS 25-Hydroxy Vitamin DS	2015-01-30
PMN K140554 | JJX Immunodiagnostic Systems SA [IMMUNODIAGNOSTIC SYSTEMS LTD.]	IDS-iSYS 25-Hydroxy Vitamin DS Control Set	2015-01-30
PMN K123763 | CIB Immunodiagnostic Systems SA [IMMUNODIAGNOSTIC SYSTEMS LTD.]	IDS-iSYS Direct Renin	2013-12-31
PMN K123763 | CIB Immunodiagnostic Systems SA [IMMUNODIAGNOSTIC SYSTEMS LTD.]	IDS-iSYS Direct Renin Control Set	2013-12-31
PMN K123763 | CIB Immunodiagnostic Systems SA [IMMUNODIAGNOSTIC SYSTEMS LTD.]	IDS-iSYS Direct Renin Calibration Verifiers	2013-12-31
PMN K123253 | MRG Immunodiagnostic Systems SA [IMMUNODIAGNOSTIC SYSTEMS LTD.]	IDS iSYS 1,25 Dihydroxy Vitamin D	2013-06-24
PMN K123253 | MRG Immunodiagnostic Systems SA [IMMUNODIAGNOSTIC SYSTEMS LTD.]	IDS iSYS 1,25 Dihydroxy Vitamin D Control Set	2013-06-24
PMN K123253 | JJX Immunodiagnostic Systems SA [IMMUNODIAGNOSTIC SYSTEMS LTD.]	IDS iSYS 1,25 Dihydroxy Vitamin D	2013-06-24
PMN K123253 | JJX Immunodiagnostic Systems SA [IMMUNODIAGNOSTIC SYSTEMS LTD.]	IDS iSYS 1,25 Dihydroxy Vitamin D Control Set	2013-06-24
PMN K111938 | JJX Immunodiagnostic Systems SA [IMMUNODIAGNOSTIC SYSTEMS LTD.]	IDS-iSYS hGH Calibration Verifier	2012-02-17
PMN K111938 | JJX Immunodiagnostic Systems SA [IMMUNODIAGNOSTIC SYSTEMS LTD.]	IDS-iSYS Insulin-like Growth Factor Binding Protein-3 (IGFBP-3) Calibration Verifiers	2012-02-17
PMN K111938 | JJX Immunodiagnostic Systems SA [IMMUNODIAGNOSTIC SYSTEMS LTD.]	IDS-iSYS Insulin-like Growth Factor Binding Protein 3 (IGFBP-3) Control Set	2012-02-17
PMN K111938 | JJX Immunodiagnostic Systems SA [IMMUNODIAGNOSTIC SYSTEMS LTD.]	IDS-iSYS IGFBP-3 Control Set	2012-02-17
PMN K111938 | JJX Immunodiagnostic Systems SA [IMMUNODIAGNOSTIC SYSTEMS LTD.]	IDS-iSYS IGFBP-3 Calibration Verifier	2012-02-17
PMN K111938 | JJX Immunodiagnostic Systems SA [IMMUNODIAGNOSTIC SYSTEMS LTD.]	IDS-iSYS Human Growth Hormone Calibration Verifiers	2012-02-17
PMN K103325 | JJX Immunodiagnostic Systems SA [IMMUNODIAGNOSTIC SYSTEMS LTD.]	IDS-iSYS iPTH Control Set	2012-02-13
PMN K103325 | JJX Immunodiagnostic Systems SA [IMMUNODIAGNOSTIC SYSTEMS LTD.]	IDS-iSYS iPTH Calibrator	2012-02-13
PMN K103325 | JJX Immunodiagnostic Systems SA [IMMUNODIAGNOSTIC SYSTEMS LTD.]	IDS-iSYS iPTH Calibration Verifier	2012-02-13
PMN K103325 | JJX Immunodiagnostic Systems SA [IMMUNODIAGNOSTIC SYSTEMS LTD.]	IDS-iSYS iPTH Assay	2012-02-13
PMN K103325 | JJX Immunodiagnostic Systems SA [IMMUNODIAGNOSTIC SYSTEMS LTD.]	IDS-iSYS Intact PTH	2012-02-13
PMN K103325 | JJX Immunodiagnostic Systems SA [IMMUNODIAGNOSTIC SYSTEMS LTD.]	IDS-iSYS Intact PTH Control Set	2012-02-13
PMN K103325 | JJX Immunodiagnostic Systems SA [IMMUNODIAGNOSTIC SYSTEMS LTD.]	IDS-iSYS Intact PTH Calibration Verifiers	2012-02-13
PMN K103325 | JIT Immunodiagnostic Systems SA [IMMUNODIAGNOSTIC SYSTEMS LTD.]	IDS-iSYS iPTH Control Set	2012-02-13
PMN K103325 | JIT Immunodiagnostic Systems SA [IMMUNODIAGNOSTIC SYSTEMS LTD.]	IDS-iSYS iPTH Calibrator	2012-02-13
PMN K103325 | JIT Immunodiagnostic Systems SA [IMMUNODIAGNOSTIC SYSTEMS LTD.]	IDS-iSYS iPTH Calibration Verifier	2012-02-13
PMN K103325 | JIT Immunodiagnostic Systems SA [IMMUNODIAGNOSTIC SYSTEMS LTD.]	IDS-iSYS iPTH Assay	2012-02-13
PMN K103325 | JIT Immunodiagnostic Systems SA [IMMUNODIAGNOSTIC SYSTEMS LTD.]	IDS-iSYS Intact PTH	2012-02-13
PMN K103325 | JIT Immunodiagnostic Systems SA [IMMUNODIAGNOSTIC SYSTEMS LTD.]	IDS-iSYS Intact PTH Control Set	2012-02-13
PMN K103325 | JIT Immunodiagnostic Systems SA [IMMUNODIAGNOSTIC SYSTEMS LTD.]	IDS-iSYS Intact PTH Calibration Verifiers	2012-02-13
PMN K103325 | CEW Immunodiagnostic Systems SA [IMMUNODIAGNOSTIC SYSTEMS LTD.]	IDS-iSYS iPTH Control Set	2012-02-13
PMN K103325 | CEW Immunodiagnostic Systems SA [IMMUNODIAGNOSTIC SYSTEMS LTD.]	IDS-iSYS iPTH Calibrator	2012-02-13
PMN K103325 | CEW Immunodiagnostic Systems SA [IMMUNODIAGNOSTIC SYSTEMS LTD.]	IDS-iSYS iPTH Calibration Verifier	2012-02-13
PMN K103325 | CEW Immunodiagnostic Systems SA [IMMUNODIAGNOSTIC SYSTEMS LTD.]	IDS-iSYS iPTH Assay	2012-02-13
PMN K103325 | CEW Immunodiagnostic Systems SA [IMMUNODIAGNOSTIC SYSTEMS LTD.]	IDS-iSYS Intact PTH	2012-02-13
PMN K103325 | CEW Immunodiagnostic Systems SA [IMMUNODIAGNOSTIC SYSTEMS LTD.]	IDS-iSYS Intact PTH Control Set	2012-02-13
PMN K103325 | CEW Immunodiagnostic Systems SA [IMMUNODIAGNOSTIC SYSTEMS LTD.]	IDS-iSYS Intact PTH Calibration Verifiers	2012-02-13
PMN K111650 | JJX Immunodiagnostic Systems SA [IMMUNODIAGNOSTIC SYSTEMS LTD.]	IDS-iSYS CTX-I (Crosslaps) Control Set	2011-09-12
PMN K111650 | JJX Immunodiagnostic Systems SA [IMMUNODIAGNOSTIC SYSTEMS LTD.]	IDS-iSYS CTX-I (Crosslaps) Calibration Verifiers	2011-09-12
PMN K111650 | JJX Immunodiagnostic Systems SA [IMMUNODIAGNOSTIC SYSTEMS LTD.]	IDS-iSYS 25 VitDS Calibration Verifiers	2011-09-12
PMN K111650 | JJX Immunodiagnostic Systems SA [IMMUNODIAGNOSTIC SYSTEMS LTD.]	IDS-iSYS 25 Hydroxy Vitamin D Calibration Verifiers	2011-09-12
PMN K110412 | JJX Immunodiagnostic Systems SA [IMMUNODIAGNOSTIC SYSTEMS LTD.]	IDS-iSYS Insulin like Growth Factor?I (IGF-I) Control Set	2011-04-12
PMN K091849 | MRG Immunodiagnostic Systems SA [IMMUNODIAGNOSTIC SYSTEMS LTD.]	IDS-iSYS Multi Discipline Automated System	2010-07-13
PMN K091849 | MRG Immunodiagnostic Systems SA [IMMUNODIAGNOSTIC SYSTEMS LTD.]	IDS-iSYS 25-Hydroxy Vitamin D	2010-07-13
PMN K091849 | MRG Immunodiagnostic Systems SA [IMMUNODIAGNOSTIC SYSTEMS LTD.]	IDS-iSYS 25-Hydroxy Vitamin D Control Set	2010-07-13
PMN K091849 | MRG Immunodiagnostic Systems SA [IMMUNODIAGNOSTIC SYSTEMS LTD.]	IDS-i10	2010-07-13
PMN K091849 | JJX Immunodiagnostic Systems SA [IMMUNODIAGNOSTIC SYSTEMS LTD.]	IDS-iSYS Multi Discipline Automated System	2010-07-13
PMN K091849 | JJX Immunodiagnostic Systems SA [IMMUNODIAGNOSTIC SYSTEMS LTD.]	IDS-iSYS 25-Hydroxy Vitamin D	2010-07-13
PMN K091849 | JJX Immunodiagnostic Systems SA [IMMUNODIAGNOSTIC SYSTEMS LTD.]	IDS-iSYS 25-Hydroxy Vitamin D Control Set	2010-07-13
PMN K091849 | JJX Immunodiagnostic Systems SA [IMMUNODIAGNOSTIC SYSTEMS LTD.]	IDS-i10	2010-07-13
PMN K091849 | JJE Immunodiagnostic Systems SA [IMMUNODIAGNOSTIC SYSTEMS LTD.]	IDS-iSYS Multi Discipline Automated System	2010-07-13
PMN K091849 | JJE Immunodiagnostic Systems SA [IMMUNODIAGNOSTIC SYSTEMS LTD.]	IDS-iSYS 25-Hydroxy Vitamin D	2010-07-13
PMN K091849 | JJE Immunodiagnostic Systems SA [IMMUNODIAGNOSTIC SYSTEMS LTD.]	IDS-iSYS 25-Hydroxy Vitamin D Control Set	2010-07-13
PMN K091849 | JJE Immunodiagnostic Systems SA [IMMUNODIAGNOSTIC SYSTEMS LTD.]	IDS-i10	2010-07-13
JJE Immunodiagnostic Systems SA [IMMUNODIAGNOSTIC SYSTEMS LTD.]	IDS-iSYS Wash Solution	2009-12-02
JJE Immunodiagnostic Systems SA [IMMUNODIAGNOSTIC SYSTEMS LTD.]	IDS-iSYS Wash Solution (Wash S)	2009-12-02
JJE Immunodiagnostic Systems SA [IMMUNODIAGNOSTIC SYSTEMS LTD.]	IDS-iSYS Trigger Set	2009-12-02
JJE Immunodiagnostic Systems SA [IMMUNODIAGNOSTIC SYSTEMS LTD.]	IDS-iSYS System Liquid	2009-12-02
JJE Immunodiagnostic Systems SA [IMMUNODIAGNOSTIC SYSTEMS LTD.]	IDS-iSYS System Liquid (Syst.l)	2009-12-02
JJE Immunodiagnostic Systems SA [IMMUNODIAGNOSTIC SYSTEMS LTD.]	IDS-iSYS D-Sorb Solution	2009-12-02
JJE Immunodiagnostic Systems SA [IMMUNODIAGNOSTIC SYSTEMS LTD.]	IDS-iSYS Cuvettes	2009-12-02
JJE Immunodiagnostic Systems SA [IMMUNODIAGNOSTIC SYSTEMS LTD.]	IDS-iSYS Cartridge Check System (CCS)	2009-12-02
JJE Immunodiagnostic Systems SA [IMMUNODIAGNOSTIC SYSTEMS LTD.]	IDS-iSYS Analyser	2009-12-02
JJE Immunodiagnostic Systems SA [IMMUNODIAGNOSTIC SYSTEMS LTD.]	IDS Immunocleaner	2009-12-02