FDA.reportPublic FDA data

Immunodiagnostic Systems SA

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
30075006353007500635Immunodiagnostic Systems SA1N2026-01-01Rue Ernest Solvay 101 Liege BE 4000

GUDID Contact Samples#

Sampled from matched GUDID device records for this company; this is not an exhaustive company contact directory.

Source GUDID, Product, Phone table
Source GUDIDProductPhoneEmail
05425030421017IDS-iSYS System Liquid (Syst. l) - IS-CS100+32042522636info.be@idsplc.com
05425030421024IDS-iSYS Trigger Set - IS-CT100+32042522636info.be@idsplc.com

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
1109891492641294K161831IDS-iSYS 25VitDs, IDS-iSYS 25VitDs Control SetMRG2016-11-15
1109891480775234K161158IDS-iSYS Intact PTHNCEW2017-01-31
1109891750791828K161082IDS-iSYS 17-OH Progesterone Control Set, IDS-iSYS 17-OH Progesterone Calibration VerifiersJJX2016-05-17
1109891337077695K142994IDS-iSYS Aldosterone,IDS iSYS Aldosterone Control Set, and IDS iSYS Aldosterone Calibration VerifiersCJM2015-04-21
1109891911715828K140554IDS-ISYS 25-HYDROXY VITAMIN DS, AND IDS-ISYS 25 HYDROXY VITAMIN DS CONTROL SETMRG2014-12-19
1109891886741941K123763IDS ISYS DIRECT RENIN ASSAY, IDS ISYS DIRECT RENIN CONTROL SET, AND IDS ISYS DIRECT RENIN CALIBRATION VERIFIERSCIB2013-12-24
1109891943790296K123253IDS ISYS 1,25 DIHYDROXY VITAMIN D, IDS-ISYS, 1,25 DIHYDROXY VITAMIN D CONTROL SET, AND IDS ISYS 1,25 DIHYDROXY VITAMIN DMRG2013-06-18
1109891112353351K111938IDS-ISYS IGFBP-3 CONTROL SET, IDS-ISYS HUMAN GROWTH HORMONE (HGH) CALIBRATION VERIFIERS, AND IDS-ISYS IGFBP-3 CAL...JJX2012-02-14
1109892017450441K111650IDS-ISYS CTX-1 (CROSSLAPS) CALIBRATION VERIFIERS, IDS-ISYS 25 HYDROXY VITAMIN D CALIBRATION VERIFIERS, AND IDS-ISYS...JJX2011-09-06
1109891305622030K110412IDS-ISYS IFG-I CONTROL SETJJX2011-03-16
1109891822477991K103325IDS-ISYS INTACT PTHCEW2012-02-03
1109891715850133K091849IDS-ISYS 25-HYDROXY VITAMIN D ASSAY, IDS-ISYS 25-HYDROXY VITAMIN D CONTROL SETMRG2010-06-25
1109891167610455

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
MRG42016-11-15
JJX42016-05-17
CEW22017-01-31
CJM12015-04-21
CIB12013-12-24

GUDID#