FDA.reportPublic FDA data

Multiple clinical chemistry analyte IVD, calibrator

Definition
A material which is used to establish known points of reference for a number of assays intended to be used for the qualitative and/or quantitative detection of one or multiple clinical chemistry analytes, and which together create a full general biochemistry profile.
GUDID devices
93
Last updated
2020-09-07 16:22:32

Representative GUDID Devices#

Primary DI, Brand, Company table
Primary DIBrandCompanyModelPublished
03610230007426Yumizen C1200 Multi CalHORIBA ABX SAS13000238902020-08-28
00380740161361ARCHITECTAbbott GmbH1E65-062020-05-23
00380740163365ARCHITECTAbbott GmbH1E46-042019-08-15
00840937111895ImmunalysisIMMUNALYSIS CORP10055-102020-03-31
00840937111918ImmunalysisIMMUNALYSIS CORP10056-102020-03-31
00840937111925ImmunalysisIMMUNALYSIS CORP10057-102020-03-31
00840937111932ImmunalysisIMMUNALYSIS CORP10058-102020-03-31
00840937111956Immunalysis CorporationIMMUNALYSIS CORPORATIONNegOFC-01002020-03-31
00840937111963Immunalysis CorporationIMMUNALYSIS CORPORATIONNegOFC-05002020-03-31
00853366007448PHOENIX DIAGNOSTICS, INC.PHOENIX DIAGNOSTICS, INC.PH70002018-01-26
00853366007455PHOENIX DIAGNOSTICS, INC.PHOENIX DIAGNOSTICS, INC.PH70012018-01-26
04015630932276cobas U Calibration StripRoche Diagnostics GmbH063905790012019-09-05
10758750032105VITROSORTHO-CLINICAL DIAGNOSTICS, INC.68445082019-06-14
15099590131180AUBECKMAN COULTER IRELAND INC.663002016-09-24
15099590180218SynchronBeckman Coulter, Inc.4699652016-08-24
15099590221256SynchronBeckman Coulter, Inc.4699752016-08-24
15099590223243IMMAGEBeckman Coulter, Inc.4684292016-08-24
15099590223465SynchronBeckman Coulter, Inc.4413502016-08-24
15099590233037SynchronBeckman Coulter, Inc.4426002016-08-24
15099590233105SynchronBeckman Coulter, Inc.4427722016-08-24
15099590233389SynchronBeckman Coulter, Inc.4684052016-08-24
15099590233402SynchronBeckman Coulter, Inc.4712882016-08-24
15099590233419SynchronBeckman Coulter, Inc.4712912016-08-24
15099590233426SynchronBeckman Coulter, Inc.4712942016-08-24
15099590635534AUBeckman Coulter, Inc.DR00902016-09-24
15099590635565AUBeckman Coulter, Inc.DR00912016-09-24
15099590635572AUBECKMAN COULTER IRELAND INC.DR0070-22016-09-24
15099590635602AUBECKMAN COULTER IRELAND INC.DR0070-12016-09-24
05055273200959CAL 2RANDOX LABORATORIES LIMITEDCAL23502016-09-16
05055273200966CAL 3RANDOX LABORATORIES LIMITEDCAL23512016-09-16
05055273205954CAL BRANDOX LABORATORIES LIMITEDRX39492016-09-26
05055273206098CAL ARANDOX LABORATORIES LIMITEDRX40002016-09-26
05055273214321L SOLNRANDOX LABORATORIES LIMITEDRX40442016-09-26
05055273214345H SOLNRANDOX LABORATORIES LIMITEDRX40462016-09-26
05055273214888L SOLNRANDOX LABORATORIES LIMITEDD400-00182016-09-26
05060500091538Synermed®INFRARED LABORATORY SYSTEMS LLCIR9542016-09-20
05060500091590Synermed®INFRARED LABORATORY SYSTEMS LLCISE530-K2016-09-20
05060500091613Synermed®INFRARED LABORATORY SYSTEMS LLC0012016-09-20
05060500091637Synermed®INFRARED LABORATORY SYSTEMS LLC08532016-09-20
05060500091644Synermed®INFRARED LABORATORY SYSTEMS LLC08542016-09-20
05060500091651Synermed®INFRARED LABORATORY SYSTEMS LLC08552016-09-20
05060500092023Synermed®INFRARED LABORATORY SYSTEMS LLCIR952-DAU2017-04-27
00842768004995Dimension® CHEM II CalibratorSiemens Healthcare Diagnostics Inc.104449972016-09-24
00842768005091Dimension® TP/ALB CalibratorSiemens Healthcare Diagnostics Inc.104449932016-09-24
00842768013683Dimension® Thyroid CalibratorSiemens Healthcare Diagnostics Inc.104450182016-09-24
00842768013751Dimension® clinical chemistry system T/F PSA CalibratorSiemens Healthcare Diagnostics Inc.104450312014-09-24
00842768015793Dimension Vista® CHEM 2 CALSiemens Healthcare Diagnostics Inc.104451702016-09-24
00842768015816Dimension Vista® CHEM 4 CALSiemens Healthcare Diagnostics Inc.104451722016-09-24
00842768015823Dimension Vista® BILI CALSiemens Healthcare Diagnostics Inc.104602792016-09-24
00842768016813Dimension® TBI/DBI CalibratorSiemens Healthcare Diagnostics Inc.104450132016-09-24
00842768024214Dimension Vista® System PSA CALSiemens Healthcare Diagnostics Inc.104643592014-09-24
00842768029325Dimension Vista® LOCI 6 CALSiemens Healthcare Diagnostics Inc.104884442016-09-24
00842768029332Dimension Vista® LOCI 7 CALSiemens Healthcare Diagnostics Inc.104884462016-09-24
00842768033827Dimension Vista® LOCI 4 CALSiemens Healthcare Diagnostics Inc.104761722016-09-24
00845275000719Thermo Scientific Pacific Hemostasis®Fisher Diagnostics1002402016-07-18
00857969006181Alfa WassermannALFA WASSERMANN, INC.S1-332016-09-24
00857969006198Alfa WassermannALFA WASSERMANN, INC.S2-852016-09-24
00075537180075Calibration Strip (Urisys 1100, cobas u 411)Roche Diagnostics GmbH113791941602016-09-20
00817439020321Calibrator Level 1 Medtest Dx, Inc.CA11002016-09-30
00817439020338Calibration Serum Level 2Medtest Dx, Inc.CA14002016-09-30
00811727010704POINTE SCIENTIFIC Chemistry CalibratorHORIBA INSTRUMENTS INCORPORATEDC7506-502016-08-31
00811727013972Pointe Scientific, Inc.HORIBA INSTRUMENTS INCORPORATED13-C7506-DIL-552016-08-31
00812137012111Chemistry Calibrator SetCLINICAL DIAGNOSTIC SOLUTIONS, INC.10 x 5mL, 1 x 50mL2016-10-12
00657498001127Ser-T-Cal MulticalibratorSTANBIO LABORATORY, L.P.0550-6052016-09-23
00657498001752Sirrus® ISE Calibrator 1STANBIO LABORATORY, L.P.202704772016-09-24
00657498001769Sirrus® ISE Calibrator 2STANBIO LABORATORY, L.P.202704782016-09-24
00657498001790Standard 2STANBIO LABORATORY, L.P.A469-982016-09-24
00657498001806Standard 1STANBIO LABORATORY, L.P.A469-972016-09-24
00630414223414ADVIA® Chemistry CalibratorSiemens Healthcare Diagnostics Inc.103122792016-09-24
00630414475677ADVIA® Chemistry Special Chemistry CalibratorSiemens Healthcare Diagnostics Inc.103119262016-09-24
00630414479286ADVIA® Chemistry ToxAmmonia CalSiemens Healthcare Diagnostics Inc.103092172016-09-24
00630414482453ADVIA® Chemistry LSP Liquid Specific Protein CalibratorsSiemens Healthcare Diagnostics Inc.103119292016-09-24
00630414597218Atellica CH ALP_2 CalibratorSiemens Healthcare Diagnostics Inc.110993162017-12-22
00630414597379Atellica CH CHEM III CalibratorSiemens Healthcare Diagnostics Inc.110993352017-12-22
00630414597492Atellica CH CHEM CalibratorSiemens Healthcare Diagnostics Inc.110994112017-12-27
00630414597553Atellica CH LSP CalibratorSiemens Healthcare Diagnostics Inc.110994342017-12-27
00630414597591Atellica CH SPCL CHEM CalibratorSiemens Healthcare Diagnostics Inc.110994382018-02-06
00630414597614Atellica CH TOX CalibratorSiemens Healthcare Diagnostics Inc.110994402018-02-06
00630414601199ADVIA® Chemistry Alkaline Phosphatase (ALP_2) CalibratorSiemens Healthcare Diagnostics Inc.109160602016-09-24
00630414948027Dimension Vista® CHEM 3 CALSiemens Healthcare Diagnostics Inc.107115792016-09-24