FDA.reportPublic FDA data

Access Ferritin

Primary DI
15099590772840
Brand
Access Ferritin
Company
Beckman Coulter, Inc.
Model
C22490
Catalog number
C22490
Device description
The Access Ferritin assay is a paramagnetic particle, chemiluminescent immunoassay for the quantitative determination of ferritin levels in human serum and plasma (heparin) using the Access Immunoassay Systems. Ferritin is used as an aid in the diagnosis of iron deficiency or iron overload.
Published
2024-04-05
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

Code, Name table
CodeName
JMGRadioimmunoassay (Two-Site Solid Phase), Ferritin

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
JMGRadioimmunoassay (Two-Site Solid Phase), FerritinImmunology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
15099590772840PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1509959077284015099590772840

GMDN Terms#

Term, Definition table
TermDefinition
Ferritin IVD, kit, enzyme immunoassay (EIA)A collection of reagents and other associated materials intended to be used for the quantitative measurement of ferritin in a clinical specimen, using an enzyme immunoassay (EIA) 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
00842768000119Dimension® Sample DiluentSiemens Healthcare Diagnostics Inc.JMG2020-09-24
00842768013768Dimension® Reagent Probe CleanerSiemens Healthcare Diagnostics Inc.JMG2020-09-24
00842768013775Dimension® Sample Probe CleanerSiemens Healthcare Diagnostics Inc.JMG2020-09-24
00842768013782Dimension® IMT Probe CleanerSiemens Healthcare Diagnostics Inc.JMG2020-09-24
00842768014277Dimension® Chemistry WashSiemens Healthcare Diagnostics Inc.JMG2020-09-24
00816870020303Ferritin AccuBind ELISA Test System - 96 WellsMONOBIND, INC.JMG2019-02-11
00816870020310Ferritin AccuBind ELISA Test System - 192 WellsMONOBIND, INC.JMG2019-02-11
00816870021980Ferritin AccuLite CLIA Test System - 96 WellsMONOBIND, INC.JMG2019-02-11
00816870021997Ferritin AccuLite CLIA Test System - 192 WellsMONOBIND, INC.JMG2019-02-11
00842768013928Dimension® Reaction VesselsSiemens Healthcare Diagnostics Inc.JMG2018-09-24
04015630939688Elecsys FerritinRoche Diagnostics GmbHJMG2017-04-21
00842768013867Dimension® Flex® reagent cartridge FERRSiemens Healthcare Diagnostics Inc.JMG2016-09-24
00630414953748IMMULITE®/IMMULITE® 1000 Systems FER Ferritin Sample DiluentSIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTDJMG2016-09-24
00630414961460IMMULITE® 2000 Systems FER FerritinSIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTDJMG2016-09-24
00630414961477IMMULITE® 2000 Systems FER FerritinSIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTDJMG2016-09-24
00630414963976IMMULITE®/IMMULITE® 1000 Systems FER FerritinSIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTDJMG2016-09-24
04015630920242Elecsys Ferritin CalSetRoche Diagnostics GmbHJMG2016-09-20
04015630938940Elecsys FerritinRoche Diagnostics GmbHJMG2016-09-20
04015630938957Elecsys FerritinRoche Diagnostics GmbHJMG2016-09-20
15099590575045Access Ferritin CalibratorsBeckman Coulter, Inc.JMG2016-09-09
15099590575052Access FerritinBeckman Coulter, Inc.JMG2016-09-09