FDA.reportPublic FDA data

IMMAGE

Primary DI
15099590227029
Brand
IMMAGE
Company
Beckman Coulter, Inc.
Model
474620
Catalog number
474620
Device description
IMMAGE Immunochemistry Systems IGE Total Immunoglobulin E Reagent
Published
2016-08-24
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

Product Codes#

Code, Name table
CodeName
CFNMethod, Nephelometric, Immunoglobulins (G, A, M)
DGCIge, Antigen, Antiserum, Control

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
CFNMethod, Nephelometric, Immunoglobulins (G, A, M)Immunology2
DGCIge, Antigen, Antiserum, ControlImmunology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K024210000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K024210000IMMAGE SYSTEMS TOTAL IMMUNOGLOBULIN E (IGE) REAGENT IMMAGE IGE CALIBRATORBeckman Coulter, Inc.2003-02-24DGC

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
15099590227029PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1509959022702915099590227029

GMDN Terms#

Term, Definition table
TermDefinition
Total immunoglobulin E (IgE total) IVD, antibodyOne or multiple immunoglobulins capable of binding to specific antigenic determinants and intended to be used for the qualitative and/or quantitative detection of total immunoglobulin E (IgE total) in a clinical specimen.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
008254708
Device count
1
Kit
true
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
15099590799250MicroScanV5.03 PU11D233542025-12-08
15099590807146MicroScanV5.03 DD07ED336042025-12-08
15099590799243MicroScanV5.03 PU11ED233522025-12-08
15099590807696UniCel DxH 900 COULTER Cellular Analysis System (Rebuilt by Beckman Coulter)D30863D308632026-05-19
15099590806323Access anti-HBc IgM D22920D229202026-05-04
15099590806330Access anti-HBc IgM CalibratorD22921D229212026-05-04
15099590806347Access anti-HBc IgM QCD22922D229222026-05-04
15099590806446Access anti-HAV IgMD25834D258342026-04-23
15099590806453Access anti-HAV IgM CalibratorD25835D258352026-04-23
15099590806460Access anti-HAV IgM QCD25836D258362026-04-23
15099590233501Synchron4725004725002016-08-24
15099590786533Access BNP IID06227D062272026-03-30
15099590806293Hepatitis B Virus core Total AntibodyD22917D229172026-03-30
15099590806309ACCESS anti-HBc Total CALIBRATORD22918D229182026-03-30
15099590806316ACCESS anti-HBc Total QCD22919D229192026-03-30
15099590572822Cytomics FC500UPS (MPL)6265542016-09-23
15099590572839Cytomics FC500UPS (CXP)6265532016-09-23
15099590736002Access PCTC53987C539872023-05-05
15099590806255ACCESS HBsAgD229132026-01-16
15099590806262ACCESS HBsAg ConfirmatoryD229142026-01-16

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00816870024400IgE-XR AccuBind ELISA Test System - 96 WellsMONOBIND, INC.DGC2024-09-13
00850054026477QMedix™Diagnostic Automation, Inc.DGC2024-01-31
00380740153700AlinityABBOTT LABORATORIESDGC2023-10-14
05051700021036Optilite® IgG3 Kit (x10)THE BINDING SITE GROUP LIMITEDCFN2023-09-27
05051700021043Optilite® IgG4 Kit (x10)THE BINDING SITE GROUP LIMITEDCFN2023-09-27
04048474017885Immunoglobulin E (IgE) ELISADRG Instruments Gesellschaft mit beschränkter HaftungDGC2023-08-26
05051700020916Optilite® IgG Kit (x10)THE BINDING SITE GROUP LIMITEDCFN2022-11-21
05051700020923Optilite® IgG1 Kit (x10)THE BINDING SITE GROUP LIMITEDCFN2022-11-21
05051700020930Optilite® IgG2 Kit (x10)THE BINDING SITE GROUP LIMITEDCFN2022-11-21
15099590701727Total Immunoglobulin E (IgE)Beckman Coulter, Inc.DGC2022-05-03
00840239017888Immunoglobulin E (IgE) ELISADRG International IncDGC2021-06-07
00630414285023N Latex IgMSiemens Healthcare Diagnostics Products GmbHCFN2020-05-29
00380740156282ARCHITECTABBOTT LABORATORIESDGC2020-03-03
00380740156367ARCHITECTABBOTT LABORATORIESDGC2020-03-03
00380740156404ARCHITECTABBOTT LABORATORIESDGC2020-03-03
05051700020183Optilite IgM CSF KitTHE BINDING SITE GROUP LIMITEDCFN2020-01-31
00850392007350BioCheck IgE EIA Test KitBIOCHECK, INC.DGC2019-10-08
05051700020190Optilite IgA CSF KitTHE BINDING SITE GROUP LIMITEDCFN2019-06-21
07333066019864ImmunoCAP Total IgE Conjugate 400Phadia ABDGC2019-03-29
07333066000664ImmunoCAP Total IgE Conjugate 400Phadia ABDGC2019-03-29
07333066019772ImmunoCAP Total IgE Conjugate 100Phadia ABDGC2019-03-28
07333066019789ImmunoCAP Total IgE Curve Control StripPhadia ABDGC2019-03-28
07333066019796ImmunoCAP Total IgE Calibrator StripPhadia ABDGC2019-03-28
07333066000206ImmunoCAP Total IgE Conjugate 100Phadia ABDGC2019-03-28
07333066000220ImmunoCAP Total IgE Curve Control StripPhadia ABDGC2019-03-28
07333066000367ImmunoCAP Total IgE Calibrator StripPhadia ABDGC2019-03-28
07333066019512ImmunoCAP Total IgE CalibratorsPhadia ABDGC2019-03-26
07333066019529ImmunoCAP Total IgE Curve ControlsPhadia ABDGC2019-03-26
07333066019642ImmunoCAP Total IgE Control LMHPhadia ABDGC2019-03-26
07333066019673ImmunoCAP Total IgEPhadia ABDGC2019-03-26