FDA.reportPublic FDA data

IMMAGE

Primary DI
15099590230470
Brand
IMMAGE
Company
Beckman Coulter, Inc.
Model
446460
Catalog number
446460
Device description
IMMAGE Immunochemistry Systems IGA Immunoglobulin A 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)

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
CFNMethod, Nephelometric, Immunoglobulins (G, A, M)Immunology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K963868000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K963868000IMMAGE IMMUNOCHEMISTRY SYSTEM IMMUNOGLOBULIN G (IGG), A (IGA) AND M (IGM)Beckman Instruments, Inc.1997-02-10DEW

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
15099590230470PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1509959023047015099590230470

GMDN Terms#

Term, Definition table
TermDefinition
Total immunoglobulin A (IgA total) IVD, kit, nephelometry/turbidimetryA collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of total immunoglobulin A (IgA total) in a clinical specimen, using a nephelometry/turbidimetry method.

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
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
15099590806279Access HBsAg CALIBRATORD229152026-01-16
15099590806286ACCESS HBsAg QCD229162026-01-16
15099590806415ACCESS anti-HAVD258312026-01-16

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
05051700021036Optilite® IgG3 Kit (x10)THE BINDING SITE GROUP LIMITEDCFN2023-09-27
05051700021043Optilite® IgG4 Kit (x10)THE BINDING SITE GROUP LIMITEDCFN2023-09-27
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
00630414285023N Latex IgMSiemens Healthcare Diagnostics Products GmbHCFN2020-05-29
05051700020183Optilite IgM CSF KitTHE BINDING SITE GROUP LIMITEDCFN2020-01-31
05051700020190Optilite IgA CSF KitTHE BINDING SITE GROUP LIMITEDCFN2019-06-21
00630414596266Atellica CH IgG_2Siemens Healthcare Diagnostics Inc.CFN2017-12-27
00630414595627Atellica CH IgM_2Siemens Healthcare Diagnostics Inc.CFN2017-12-21
00630414595610Atellica CH IgA_2Siemens Healthcare Diagnostics Inc.CFN2017-12-19
05051700019835Optilite IgG CSF KitTHE BINDING SITE GROUP LIMITEDCFN2017-05-26
15099590011574AUBeckman Coulter, Inc.CFN2016-09-24
15099590011581AUBeckman Coulter, Inc.CFN2016-09-24
15099590011598AUBeckman Coulter, Inc.CFN2016-09-24
05051700006033Human IgG Subclass Liquid Reagent Kit for use on the Siemens BN™II - Bulk KitTHE BINDING SITE GROUP LIMITEDCFN2016-09-24
05051700006088Human IgG Subclass Liquid Reagent Kit for use on the Siemens BN™IITHE BINDING SITE GROUP LIMITEDCFN2016-09-24
05051700006095Human IgA Subclass Liquid Latex Reagent Kit for use on the Siemens BN™II THE BINDING SITE GROUP LIMITEDCFN2016-09-24
05051700006101Human IgG3 Subclass Liquid Reagent Kit for use on the Siemens BN™II - Bulk KitTHE BINDING SITE GROUP LIMITEDCFN2016-09-24
05051700006118Olympus IgG3 KitTHE BINDING SITE GROUP LIMITEDCFN2016-09-24
05051700006132Human IgG3 Subclass Liquid Reagent Kit for use on Hitachi 911/912/917, Modular PTHE BINDING SITE GROUP LIMITEDCFN2016-09-24
05051700006149Beckman Immage IgG3 Latex KitTHE BINDING SITE GROUP LIMITEDCFN2016-09-24
05051700006163Human IgG3 Subclass Liquid Reagent Kit for use on the Siemens BN™IITHE BINDING SITE GROUP LIMITEDCFN2016-09-24
05051700006170Human IgG4 Subclass Liquid Reagent Kit for use on the Siemens BN™II) THE BINDING SITE GROUP LIMITEDCFN2016-09-24
05051700006187Human IgG4 Subclass Liquid Reagent Kit for use on the Beckman Coulter AU® seriesTHE BINDING SITE GROUP LIMITEDCFN2016-09-24
05051700006224Human IgG4 Subclass Liquid Reagent Kit for use on the Beckman IMMAGE®/IMMAGE®800THE BINDING SITE GROUP LIMITEDCFN2016-09-24
05051700006248Human IgG4 Subclass Liquid Reagent Kit for use on the Siemens BN™IITHE BINDING SITE GROUP LIMITEDCFN2016-09-24
05051700006538Human IgA2 Subclass Liquid Latex Reagent Kit for use on the Siemens BN™IITHE BINDING SITE GROUP LIMITEDCFN2016-09-24
05051700007535Human IgG Subclass Liquid Reagent Kit for use on the Siemens BN™II Bulk KitTHE BINDING SITE GROUP LIMITEDCFN2016-09-24
05051700007559Human IgG2 Subclass Liquid Reagent Kit for use on the Siemens BN™II - Bulk KitTHE BINDING SITE GROUP LIMITEDCFN2016-09-24