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 Number3007500635
FEI Number3007500635
NameImmunodiagnostic Systems SA
Owner & OperatorIMMUNODIAGNOSTIC SYSTEMS LTD.
Contact Address10 DIDCOT WAY BOLDON BUSINESS PARK
BOLDON COLLIERY GB-NOTA NE35 9PD GB
Official Correspondent
  • Mick - Henderson
  • 44-191-5190660-x
US Agent
Registration Status1
Initial ImporterN
Registration Expiration2020-04-25
Registration AddressRue Ernest Solvay 101
Liege Liege, 4000 BE
Establishment Type
  • Manufacture Medical Device
  • Manufacture Medical Device for Another Party (Contract Manufacturer)



FDA Filings

Device
Company
DeviceDate
Immunodiagnostic Systems SA
IDS-iSYS Cartridge Check System (CCS) 2019-12-23
Immunodiagnostic Systems SA
IDS-iSYS Trigger Set 2019-12-23
Immunodiagnostic Systems SA
IDS-iSYS Wash Solution (Wash S) 2018-03-29
Immunodiagnostic Systems SA
IDS-iSYS System Liquid (Syst. l) 2018-03-29
Immunodiagnostic Systems SA [IMMUNODIAGNOSTIC SYSTEMS LTD.]
IDS-iSYS Intact PTHn2017-02-01
Immunodiagnostic Systems SA [IMMUNODIAGNOSTIC SYSTEMS LTD.]
IDS-iSYS 25 VitDS2016-12-08
Immunodiagnostic Systems SA [IMMUNODIAGNOSTIC SYSTEMS LTD.]
IDS-iSYS 25 VitDS Control Set2016-12-08
Immunodiagnostic Systems SA [IMMUNODIAGNOSTIC SYSTEMS LTD.]
IDS-iSYS 25 VitDS2016-12-08
Immunodiagnostic Systems SA [IMMUNODIAGNOSTIC SYSTEMS LTD.]
IDS-iSYS 25 VitDS Control Set2016-12-08
Immunodiagnostic Systems SA [IMMUNODIAGNOSTIC SYSTEMS LTD.]
IDS-iSYS 17-OH Progesterone Control Set IDS-iSYS 17-OH Progesterone Calibration Verifiers2016-05-18
Immunodiagnostic Systems SA [IMMUNODIAGNOSTIC SYSTEMS LTD.]
IDS-iSYS Aldosterone2015-04-21
Immunodiagnostic Systems SA [IMMUNODIAGNOSTIC SYSTEMS LTD.]
IDS-iSYS Aldosterone Control Set2015-04-21
Immunodiagnostic Systems SA [IMMUNODIAGNOSTIC SYSTEMS LTD.]
IDS-iSYS Aldosterone Calibration Veifiers2015-04-21
Immunodiagnostic Systems SA [IMMUNODIAGNOSTIC SYSTEMS LTD.]
IDS-iSYS Aldosterone2015-04-21
Immunodiagnostic Systems SA [IMMUNODIAGNOSTIC SYSTEMS LTD.]
IDS-iSYS Aldosterone Control Set2015-04-21
Immunodiagnostic Systems SA [IMMUNODIAGNOSTIC SYSTEMS LTD.]
IDS-iSYS Aldosterone Calibration Veifiers2015-04-21
Immunodiagnostic Systems SA [IMMUNODIAGNOSTIC SYSTEMS LTD.]
IDS-iSYS 25-Hydroxy Vitamin DS2015-01-30
Immunodiagnostic Systems SA [IMMUNODIAGNOSTIC SYSTEMS LTD.]
IDS-iSYS 25-Hydroxy Vitamin DS Control Set2015-01-30
Immunodiagnostic Systems SA [IMMUNODIAGNOSTIC SYSTEMS LTD.]
IDS-iSYS 25-Hydroxy Vitamin DS2015-01-30
Immunodiagnostic Systems SA [IMMUNODIAGNOSTIC SYSTEMS LTD.]
IDS-iSYS 25-Hydroxy Vitamin DS Control Set2015-01-30
Immunodiagnostic Systems SA [IMMUNODIAGNOSTIC SYSTEMS LTD.]
IDS-iSYS Direct Renin2013-12-31
Immunodiagnostic Systems SA [IMMUNODIAGNOSTIC SYSTEMS LTD.]
IDS-iSYS Direct Renin Control Set2013-12-31
Immunodiagnostic Systems SA [IMMUNODIAGNOSTIC SYSTEMS LTD.]
IDS-iSYS Direct Renin Calibration Verifiers2013-12-31
Immunodiagnostic Systems SA [IMMUNODIAGNOSTIC SYSTEMS LTD.]
IDS iSYS 1,25 Dihydroxy Vitamin D2013-06-24
Immunodiagnostic Systems SA [IMMUNODIAGNOSTIC SYSTEMS LTD.]
IDS iSYS 1,25 Dihydroxy Vitamin D Control Set2013-06-24
Immunodiagnostic Systems SA [IMMUNODIAGNOSTIC SYSTEMS LTD.]
IDS iSYS 1,25 Dihydroxy Vitamin D2013-06-24
Immunodiagnostic Systems SA [IMMUNODIAGNOSTIC SYSTEMS LTD.]
IDS iSYS 1,25 Dihydroxy Vitamin D Control Set2013-06-24
Immunodiagnostic Systems SA [IMMUNODIAGNOSTIC SYSTEMS LTD.]
IDS-iSYS hGH Calibration Verifier2012-02-17
Immunodiagnostic Systems SA [IMMUNODIAGNOSTIC SYSTEMS LTD.]
IDS-iSYS Insulin-like Growth Factor Binding Protein-3 (IGFBP-3) Calibration Verifiers2012-02-17
Immunodiagnostic Systems SA [IMMUNODIAGNOSTIC SYSTEMS LTD.]
IDS-iSYS Insulin-like Growth Factor Binding Protein 3 (IGFBP-3) Control Set2012-02-17
Immunodiagnostic Systems SA [IMMUNODIAGNOSTIC SYSTEMS LTD.]
IDS-iSYS IGFBP-3 Control Set2012-02-17
Immunodiagnostic Systems SA [IMMUNODIAGNOSTIC SYSTEMS LTD.]
IDS-iSYS IGFBP-3 Calibration Verifier2012-02-17
Immunodiagnostic Systems SA [IMMUNODIAGNOSTIC SYSTEMS LTD.]
IDS-iSYS Human Growth Hormone Calibration Verifiers2012-02-17
Immunodiagnostic Systems SA [IMMUNODIAGNOSTIC SYSTEMS LTD.]
IDS-iSYS iPTH Control Set2012-02-13
Immunodiagnostic Systems SA [IMMUNODIAGNOSTIC SYSTEMS LTD.]
IDS-iSYS iPTH Calibrator2012-02-13
Immunodiagnostic Systems SA [IMMUNODIAGNOSTIC SYSTEMS LTD.]
IDS-iSYS iPTH Calibration Verifier2012-02-13
Immunodiagnostic Systems SA [IMMUNODIAGNOSTIC SYSTEMS LTD.]
IDS-iSYS iPTH Assay2012-02-13
Immunodiagnostic Systems SA [IMMUNODIAGNOSTIC SYSTEMS LTD.]
IDS-iSYS Intact PTH2012-02-13
Immunodiagnostic Systems SA [IMMUNODIAGNOSTIC SYSTEMS LTD.]
IDS-iSYS Intact PTH Control Set2012-02-13
Immunodiagnostic Systems SA [IMMUNODIAGNOSTIC SYSTEMS LTD.]
IDS-iSYS Intact PTH Calibration Verifiers2012-02-13
Immunodiagnostic Systems SA [IMMUNODIAGNOSTIC SYSTEMS LTD.]
IDS-iSYS iPTH Control Set2012-02-13
Immunodiagnostic Systems SA [IMMUNODIAGNOSTIC SYSTEMS LTD.]
IDS-iSYS iPTH Calibrator2012-02-13
Immunodiagnostic Systems SA [IMMUNODIAGNOSTIC SYSTEMS LTD.]
IDS-iSYS iPTH Calibration Verifier2012-02-13
Immunodiagnostic Systems SA [IMMUNODIAGNOSTIC SYSTEMS LTD.]
IDS-iSYS iPTH Assay2012-02-13
Immunodiagnostic Systems SA [IMMUNODIAGNOSTIC SYSTEMS LTD.]
IDS-iSYS Intact PTH2012-02-13
Immunodiagnostic Systems SA [IMMUNODIAGNOSTIC SYSTEMS LTD.]
IDS-iSYS Intact PTH Control Set2012-02-13
Immunodiagnostic Systems SA [IMMUNODIAGNOSTIC SYSTEMS LTD.]
IDS-iSYS Intact PTH Calibration Verifiers2012-02-13
Immunodiagnostic Systems SA [IMMUNODIAGNOSTIC SYSTEMS LTD.]
IDS-iSYS iPTH Control Set2012-02-13
Immunodiagnostic Systems SA [IMMUNODIAGNOSTIC SYSTEMS LTD.]
IDS-iSYS iPTH Calibrator2012-02-13
Immunodiagnostic Systems SA [IMMUNODIAGNOSTIC SYSTEMS LTD.]
IDS-iSYS iPTH Calibration Verifier2012-02-13
Immunodiagnostic Systems SA [IMMUNODIAGNOSTIC SYSTEMS LTD.]
IDS-iSYS iPTH Assay2012-02-13
Immunodiagnostic Systems SA [IMMUNODIAGNOSTIC SYSTEMS LTD.]
IDS-iSYS Intact PTH2012-02-13
Immunodiagnostic Systems SA [IMMUNODIAGNOSTIC SYSTEMS LTD.]
IDS-iSYS Intact PTH Control Set2012-02-13
Immunodiagnostic Systems SA [IMMUNODIAGNOSTIC SYSTEMS LTD.]
IDS-iSYS Intact PTH Calibration Verifiers2012-02-13
Immunodiagnostic Systems SA [IMMUNODIAGNOSTIC SYSTEMS LTD.]
IDS-iSYS CTX-I (Crosslaps) Control Set2011-09-12
Immunodiagnostic Systems SA [IMMUNODIAGNOSTIC SYSTEMS LTD.]
IDS-iSYS CTX-I (Crosslaps) Calibration Verifiers2011-09-12
Immunodiagnostic Systems SA [IMMUNODIAGNOSTIC SYSTEMS LTD.]
IDS-iSYS 25 VitDS Calibration Verifiers2011-09-12
Immunodiagnostic Systems SA [IMMUNODIAGNOSTIC SYSTEMS LTD.]
IDS-iSYS 25 Hydroxy Vitamin D Calibration Verifiers2011-09-12
Immunodiagnostic Systems SA [IMMUNODIAGNOSTIC SYSTEMS LTD.]
IDS-iSYS Insulin like Growth Factor?I (IGF-I) Control Set2011-04-12
Immunodiagnostic Systems SA [IMMUNODIAGNOSTIC SYSTEMS LTD.]
IDS-iSYS Multi Discipline Automated System2010-07-13
Immunodiagnostic Systems SA [IMMUNODIAGNOSTIC SYSTEMS LTD.]
IDS-iSYS 25-Hydroxy Vitamin D2010-07-13
Immunodiagnostic Systems SA [IMMUNODIAGNOSTIC SYSTEMS LTD.]
IDS-iSYS 25-Hydroxy Vitamin D Control Set2010-07-13
Immunodiagnostic Systems SA [IMMUNODIAGNOSTIC SYSTEMS LTD.]
IDS-i102010-07-13
Immunodiagnostic Systems SA [IMMUNODIAGNOSTIC SYSTEMS LTD.]
IDS-iSYS Multi Discipline Automated System2010-07-13
Immunodiagnostic Systems SA [IMMUNODIAGNOSTIC SYSTEMS LTD.]
IDS-iSYS 25-Hydroxy Vitamin D2010-07-13
Immunodiagnostic Systems SA [IMMUNODIAGNOSTIC SYSTEMS LTD.]
IDS-iSYS 25-Hydroxy Vitamin D Control Set2010-07-13
Immunodiagnostic Systems SA [IMMUNODIAGNOSTIC SYSTEMS LTD.]
IDS-i102010-07-13
Immunodiagnostic Systems SA [IMMUNODIAGNOSTIC SYSTEMS LTD.]
IDS-iSYS Multi Discipline Automated System2010-07-13
Immunodiagnostic Systems SA [IMMUNODIAGNOSTIC SYSTEMS LTD.]
IDS-iSYS 25-Hydroxy Vitamin D2010-07-13
Immunodiagnostic Systems SA [IMMUNODIAGNOSTIC SYSTEMS LTD.]
IDS-iSYS 25-Hydroxy Vitamin D Control Set2010-07-13
Immunodiagnostic Systems SA [IMMUNODIAGNOSTIC SYSTEMS LTD.]
IDS-i102010-07-13
Immunodiagnostic Systems SA [IMMUNODIAGNOSTIC SYSTEMS LTD.]
IDS-iSYS Wash Solution2009-12-02
Immunodiagnostic Systems SA [IMMUNODIAGNOSTIC SYSTEMS LTD.]
IDS-iSYS Wash Solution (Wash S)2009-12-02
Immunodiagnostic Systems SA [IMMUNODIAGNOSTIC SYSTEMS LTD.]
IDS-iSYS Trigger Set2009-12-02
Immunodiagnostic Systems SA [IMMUNODIAGNOSTIC SYSTEMS LTD.]
IDS-iSYS System Liquid2009-12-02
Immunodiagnostic Systems SA [IMMUNODIAGNOSTIC SYSTEMS LTD.]
IDS-iSYS System Liquid (Syst.l)2009-12-02
Immunodiagnostic Systems SA [IMMUNODIAGNOSTIC SYSTEMS LTD.]
IDS-iSYS D-Sorb Solution2009-12-02
Immunodiagnostic Systems SA [IMMUNODIAGNOSTIC SYSTEMS LTD.]
IDS-iSYS Cuvettes2009-12-02
Immunodiagnostic Systems SA [IMMUNODIAGNOSTIC SYSTEMS LTD.]
IDS-iSYS Cartridge Check System (CCS)2009-12-02
Immunodiagnostic Systems SA [IMMUNODIAGNOSTIC SYSTEMS LTD.]
IDS-iSYS Analyser2009-12-02
Immunodiagnostic Systems SA [IMMUNODIAGNOSTIC SYSTEMS LTD.]
IDS Immunocleaner2009-12-02

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