FDA.reportPublic FDA data

IMMUNODIAGNOSTIC SYSTEMS LTD.

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
80219243002485711IMMUNODIAGNOSTIC SYSTEMS LTD.1N2026-01-0110 DIDCOT WAY Boldon Colliery Durham GB NE35 9PD

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
100021281920590K991998GAMMA-B 25-HYDROXY VITAMIN D RIAMRG1999-09-17
100022013645119K990843SERUM CROSSLAPS ONE STEP ELISAJMM1999-07-09
100021136117419K972666TANDEM-MP OSTASE IMMUNOENZYMETRIC ASSAYCIN1997-09-11
100021453184556K941878OCTEIA INTACT PTHCEW1994-09-07
100021499621308K253817IDS SS-A/Ro; IDS SS-A/Ro 60 kDa; IDS SS-B/LaLLL2026-08-21
100021275623961K252728IDS-iSYS Total TestosteroneCDZ2026-04-15
100021682546975K240865IDS-iSYS Free TestosteroneCDZ2024-10-23
100021045001297K223867IDS ACTH IICKG2023-08-18
100021455656066K202136IDS CortisolCGR2021-04-13
100021156995175K200475IDS-iSYS Ostase BAPCIN2020-09-30
100021756370805K190121IDS SHBGCDZ2019-06-17
100021492641294K161831IDS-iSYS 25VitDs, IDS-iSYS 25VitDs Control SetMRG2016-11-15
100021480775234K161158IDS-iSYS Intact PTHNCEW2017-01-31
100021750791828K161082IDS-iSYS 17-OH Progesterone Control Set, IDS-iSYS 17-OH Progesterone Calibration VerifiersJJX2016-05-17
100021977999162K143324IDS-iSYS CTX-I Calibration VerifiersJJX2015-03-30
100021337077695K142994IDS-iSYS Aldosterone,IDS iSYS Aldosterone Control Set, and IDS iSYS Aldosterone Calibration VerifiersCJM2015-04-21
100021472952054K14235125-Hydroxy Vitamin Ds EIAMRG2015-08-25
100021911715828K140554IDS-ISYS 25-HYDROXY VITAMIN DS, AND IDS-ISYS 25 HYDROXY VITAMIN DS CONTROL SETMRG2014-12-19
100021886741941K123763IDS ISYS DIRECT RENIN ASSAY, IDS ISYS DIRECT RENIN CONTROL SET, AND IDS ISYS DIRECT RENIN CALIBRATION VERIFIERSCIB2013-12-24
100021943790296K123253IDS 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
100021645988508K122141IDS-ISYS IGF-I CALIBRATION VERIFIERSJJX2012-08-07
100021112353351K111938IDS-ISYS IGFBP-3 CONTROL SET, IDS-ISYS HUMAN GROWTH HORMONE (HGH) CALIBRATION VERIFIERS, AND IDS-ISYS IGFBP-3 CAL...JJX2012-02-14
100022017450441K111650IDS-ISYS CTX-1 (CROSSLAPS) CALIBRATION VERIFIERS, IDS-ISYS 25 HYDROXY VITAMIN D CALIBRATION VERIFIERS, AND IDS-ISYS...JJX2011-09-06
100021305622030K110412IDS-ISYS IFG-I CONTROL SETJJX2011-03-16
100021822477991K103325IDS-ISYS INTACT PTHCEW2012-02-03
100021715850133K091849IDS-ISYS 25-HYDROXY VITAMIN D ASSAY, IDS-ISYS 25-HYDROXY VITAMIN D CONTROL SETMRG2010-06-25
100021521851965K0511101,25-DIHYDROXY VITAMIN D EIAMRG2005-07-06
100021062816010K042519GAMMA-B 1,25-DIHYDROXY VITAMIN DMRG2004-12-01
100021521175529K021163OCTEIA 25-HYDROXY VITAMIN DMRG2002-05-10
100021119306606K003609N-MID OSTEOCALCIN ONE STEP ELISA MODEL 30SC4000NEO2001-05-16
100021339261096
100021395231574
100021473691928
100021630612682
100021688757078
100021726719036
100021167610455
100021356107457
100021783654397
100021855509120
100021864948347

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
MRG132016-11-15
JJX72016-05-17
CDZ42026-04-15
CIN32020-09-30
CEW32017-01-31
NEO22001-05-16
LLL12026-08-21
CKG12023-08-18
CGR12021-04-13
CJM12015-04-21
CIB12013-12-24
JMM11999-07-09

PMN#