FDA.reportPublic FDA data

IMMUNODIAGNOSTIC SYSTEMS LTD.

Matched from indexed company URL: Immunodiagnostic Systems Limited

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
80219243002485711IMMUNODIAGNOSTIC SYSTEMS LTD.1N2026-01-0110 DIDCOT WAY Boldon Colliery Durham GB NE35 9PD
30075006353007500635Immunodiagnostic Systems SA1N2026-01-01Rue Ernest Solvay 101 Liege BE 4000
20874983004046329IMMUNODIAGNOSTIC SYSTEMS INC.1Y2020-04-25948 Clopper Rd Gaithersburg Gaithersburg MD US 20878

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
05060169690721IDS-iSYS Total Testosterone - The IDS-iSYS Total Testosterone assay is an in vitro diagnostic device intended for the quantitative determination of testosterone in human serum or plasma on the IDS system. Measurement of testosterone are used in the diagnosis and treatment of disorders involving the male sex hormones (androgens), including primary and secondary hypogonadism, delayed or precocious puberty, impotence in males and, in females hirsutism (excessive hair) and virilization (masculinization) due to tumors, polycystic ovaries, and adrenogenital syndromes.+441915190660ids-ts.global@revvity.com
05060169690745IDS Estradiol - For In Vitro Diagnostic Use For Laboratory Professional Use IDS Estradiol assay is an automated in vitro diagnostic device intended for the quantitative determination of estradiol in human serum on the IDS system. Results are to be used in conjunction with other clinical and laboratory data as an aid in the diagnosis and monitoring of estrogen disorders in the adult premenopausal female population.+4401915190660ids-ts.global@revvity.com
05060169690875IDS-iSYS Total Testosterone Control Set - The IDS-iSYS Total Testosterone Control Set is for in vitro diagnostic use, for the quality control of the IDS-iSYS Total Testosterone on the IDS System.+441915190660ids-ts.global@revvity.com
05060169690899IDS High Sensitive Estradiol Control Set - For In Vitro Diagnostic Use. For Laboratory Professional Use. The IDS High Sensitive Estradiol Control Set is for in vitro diagnostic use, for the quality control of the IDS High Sensitive Estradiol on the IDS system.+4401915190660ids-ts.global@revvity.com
05060169691063IDS-iSYS Total Testosterone Calibration Verifiers - The IDS-iSYS Total Testosterone Calibration Verifiers are an in vitro diagnostic device intended for medical purposes in the quantitative verification of assay calibration and measuring range of the IDS-iSYS Total Testosterone assay, when performed on the IDS System.+4401915190660ids-ts.global@revvity.com
05060169693630IDS High Sensitive Estradiol - For In Vitro Diagnostic Use. For Laboratory Professional Use. IDS High Sensitive Estradiol assay is an automated in vitro diagnostic device intended for the quantitative determination of estradiol in human serum on the IDS system. Results are to be used in conjunction with other clinical and laboratory data as an aid in the diagnosis and monitoring of estrogen disorders in the adult men and postmenopausal women, and paediatric population.+4401915190660ids-ts.global@revvity.com
05060169697218IDS High Sensitive Estradiol Calibrator Set - For In Vitro Diagnostic Use. For Laboratory Professional Use. The IDS High Sensitive Estradiol Calibrator Set is used for the calibration of the IDS High Sensitive Estradiol on the IDS system+4401915190660ids-ts.global@revvity.com

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
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
1109891492641294K161831IDS-iSYS 25VitDs, IDS-iSYS 25VitDs Control SetMRG2016-11-15
100021492641294K161831IDS-iSYS 25VitDs, IDS-iSYS 25VitDs Control SetMRG2016-11-15
1109891480775234K161158IDS-iSYS Intact PTHNCEW2017-01-31
100021480775234K161158IDS-iSYS Intact PTHNCEW2017-01-31
1109891750791828K161082IDS-iSYS 17-OH Progesterone Control Set, IDS-iSYS 17-OH Progesterone Calibration VerifiersJJX2016-05-17
100021750791828K161082IDS-iSYS 17-OH Progesterone Control Set, IDS-iSYS 17-OH Progesterone Calibration VerifiersJJX2016-05-17
100021977999162K143324IDS-iSYS CTX-I Calibration VerifiersJJX2015-03-30
1109891337077695K142994IDS-iSYS Aldosterone,IDS iSYS Aldosterone Control Set, and IDS iSYS Aldosterone Calibration VerifiersCJM2015-04-21
100021337077695K142994IDS-iSYS Aldosterone,IDS iSYS Aldosterone Control Set, and IDS iSYS Aldosterone Calibration VerifiersCJM2015-04-21
100021472952054K14235125-Hydroxy Vitamin Ds EIAMRG2015-08-25
1109891911715828K140554IDS-ISYS 25-HYDROXY VITAMIN DS, AND IDS-ISYS 25 HYDROXY VITAMIN DS CONTROL SETMRG2014-12-19
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
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
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
1109891112353351K111938IDS-ISYS IGFBP-3 CONTROL SET, IDS-ISYS HUMAN GROWTH HORMONE (HGH) CALIBRATION VERIFIERS, AND IDS-ISYS IGFBP-3 CAL...JJX2012-02-14
100021112353351K111938IDS-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
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
1109891305622030K110412IDS-ISYS IFG-I CONTROL SETJJX2011-03-16
100021822477991K103325IDS-ISYS INTACT PTHCEW2012-02-03
1109891822477991K103325IDS-ISYS INTACT PTHCEW2012-02-03
100021715850133K091849IDS-ISYS 25-HYDROXY VITAMIN D ASSAY, IDS-ISYS 25-HYDROXY VITAMIN D CONTROL SETMRG2010-06-25
1109891715850133K091849IDS-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
1109891167610455
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
MRG172016-11-15
JJX112016-05-17
CEW52017-01-31
CDZ42026-04-15
CIN32020-09-30
CJM22015-04-21
CIB22013-12-24
NEO22001-05-16
CKG12023-08-18
CGR12021-04-13
JMM11999-07-09

PMN#

GUDID#

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