FDA.reportPublic FDA data

Access C-Peptide

Primary DI
15099590733377
Brand
Access C-Peptide
Company
Beckman Coulter, Inc.
Model
C33451
Device description
The Access C-Peptide assay is a paramagnetic particle, chemiluminescent immunoassay for the quantitative determination of C-Peptide levels in human serum, plasma and urine using the Access Immunoassay Systems as an aid in the diagnosis and treatment of patients suspected of having diabetes or other insulin secretion disorders.
Published
2023-07-28
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
JKDRadioimmunoassay, C-Peptides Of Proinsulin

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
JKDRadioimmunoassay, C-Peptides Of ProinsulinClinical Chemistry1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
15099590733377PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1509959073337715099590733377

GMDN Terms#

Term, Definition table
TermDefinition
C-peptide IVD, kit, chemiluminescent immunoassayA collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of C-peptide in a clinical specimen, using a chemiluminescent immunoassay method.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
008254708
Device count
1
Premarket exempt
true
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
00850054026255AccuDiag™ C-Peptide ELISA KitDiagnostic Automation, Inc.JKD2026-01-27
04048474012934C-Peptide ELISADRG Instruments Gesellschaft mit beschränkter HaftungJKD2024-11-22
00840239015600Proinsulin ELISADRG International IncJKD2023-08-23
06925912718642iFlash-C-PeptideShenzhen YHLO Biotech Co., Ltd.JKD2022-10-26
00404847412932C-Peptide ELISADRG Instruments Gesellschaft mit beschränkter HaftungJKD2021-06-07
00404847415605Proinsulin ELISADRG Instruments Gesellschaft mit beschränkter HaftungJKD2021-06-07
04015630920129Elecsys C-PeptideRoche Diagnostics GmbHJKD2021-01-18
B24280CPTHUCH050STELLUX® Chemi Human C-peptide ELISA Lab PackAMERICAN LABORATORY PRODUCTS COMPANY, LTD.JKD2020-09-25
B24280CPTHUE100ALPCO C-peptide ELISA JumboAMERICAN LABORATORY PRODUCTS COMPANY, LTD.JKD2020-09-25
00630414600413Atellica IM CpSSiemens Healthcare Diagnostics Inc.JKD2020-09-24
00630414600437Atellica IM CpS MCMSiemens Healthcare Diagnostics Inc.JKD2020-09-24
00630414464053ADVIA Centaur® CpSSiemens Healthcare Diagnostics Inc.JKD2020-09-24
00630414953007IMMULITE® Systems CPE CONTROL C-PeptideSIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTDJKD2020-09-24
00630414953656IMMULITE®/IMMULITE® 1000 Systems PEP C-Peptide Sample DiluentSIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTDJKD2020-09-24
00630414953663IMMULITE® 2000 Systems PEP C-Peptide Sample DiluentSIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTDJKD2020-09-24
00630414961873IMMULITE® 2000 Systems C-PeptideSIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTDJKD2020-09-24
00630414964430IMMULITE®/IMMULITE® 1000 Systems PEP C-PeptideSIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTDJKD2020-09-24
05400569000049C-PEP-EASIADiasource Immunoassays S.A. SAJKD2020-09-14
B24280CPTHUCH010STELLUX® Chemi Human C-peptide ELISAAMERICAN LABORATORY PRODUCTS COMPANY, LTD.JKD2020-07-17
B24280CPTHUE010ALPCO C-peptide ELISAAMERICAN LABORATORY PRODUCTS COMPANY, LTD.JKD2020-07-17
B24280PINHUTCH010STELLUX® Chemi Human Total Proinsulin ELISAAMERICAN LABORATORY PRODUCTS COMPANY, LTD.JKD2020-07-17
00630414293615Atellica IM CpSSiemens Healthcare Diagnostics Inc.JKD2020-05-31
07350108630085Mercodia C-peptide ELISAMercodia ABJKD2020-04-08
07350108630092Mercodia Ultrasensitive C-peptide ELISAMercodia ABJKD2020-04-08
00380740156015ARCHITECTAbbott GmbHJKD2020-03-03
05400569000322C-PEP II-RIA-CTDiasource Immunoassays S.A. SAJKD2020-01-15
04560189212220AIA-PACK C-Peptide Control SetTOSOH CORPORATIONJKD2019-09-02
14560189212227AIA-PACK C-Peptide Control SetTOSOH CORPORATIONJKD2019-09-02
14560189213316ST AIA-PACK C-Peptide II TOSOH CORPORATIONJKD2019-07-24
04560189213340AIA-PACK C-Peptide II Sample Diluting SolutionTOSOH CORPORATIONJKD2019-07-24