FDA.reportPublic FDA data

Elecsys C-Peptide

Primary DI
04015630920129
Brand
Elecsys C-Peptide
Company
Roche Diagnostics GmbH
Model
3184897190
Catalog number
3184897190
Published
2021-01-18
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
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
04015630920129PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04015630920129040156309201294015630920129

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
315028860
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
07613336235546PreciControl HIV Gen II09465006160094650061602026-05-22
07613336200544cobas c 703 analytical unit09502971001095029710012026-03-20
07613336220191cobas pro SBL c 70309796754001097967540012026-03-20
07613336222331ISE Internal Standard Gen.2 conc.09137742190091377421902026-03-20
04015630926091Testosterone II CalSet II05202230190052022301902026-02-23
07613336218402Elecsys LH09755721190097557211902026-02-19
07613336236499Elecsys BRAHMS PCT10456299190104562991902026-02-19
04015630911707Elecsys Myoglobin STAT CalSet11820893122118208931222016-09-20
04015630918805Cfas PUC3121305122031213051222016-09-20
04015630919932C.f.a.s. PAC3555941190035559411902016-09-20
04015630936373Cfas Proteins11355279160113552791602016-09-20
04015630939060Elecsys Myoglobin Immunoassay12178214160121782141602016-09-20
04015630939114Elecsys BRAHMS PCT505688820050568882002016-09-20
04015630940073Elecsys BRAHMS PCT07301715190073017151902017-04-21
07613336224281PreciControl Rubella IgG09966625190099666251902026-01-28
07613336206737VENTANA DP 600 slide scanner09311360001093113600012025-12-15
07613336232125Ionify Steroids 109629645160096296451602025-12-11
07613336232132Ionify Steroids 209634444160096344441602025-12-11
07613336216958CalSet Phospho-Tau (181P) Plasma09697896190096978961902025-11-18
07613336216965PreciControl Phospho-Tau (181P) Plasma09697926190096979261902025-11-18

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
15099590733377Access C-PeptideBeckman Coulter, Inc.JKD2023-07-28
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
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 GmbH & Co. KGJKD2020-03-03
05400569000322C-PEP II-RIA-CTDiasource Immunoassays S.A. SAJKD2020-01-15
14560189212227AIA-PACK C-Peptide Control SetTOSOH CORPORATIONJKD2019-09-02
14560189213347AIA-PACK C-Peptide II Sample Diluting SolutionTOSOH CORPORATIONJKD2019-07-24
24560189213313ST AIA-PACK C-Peptide II TOSOH CORPORATIONJKD2019-07-24
00816870020730Monobind AccuBind C-Peptide ELISA Kit - 96 WellsMONOBIND, INC.JKD2019-02-11