FDA.reportPublic FDA data

VITROS

Primary DI
10758750032037
Brand
VITROS
Company
ORTHO CLINICAL DIAGNOSTICS
Model
6844423
Catalog number
6844423
Device description
VITROS Immunodiagnostic Products C-peptide Reagent Pack
Published
2018-01-12
Public version status
Update
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
20758750032034PackageGS130In Commercial Distribution
10758750032037PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
2075875003203420758750032034
1075875003203710758750032037

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.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature2 Degrees Celsius8 Degrees Celsius

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
215865786
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
10758750033287VITROS619773561977352020-05-16
10758750033294VITROS619557561955752020-05-16
10758750032891VITROS690004069000402025-12-30
10758750033522VITROS691223269122322025-12-30
10758750033539VITROS691223369122332025-12-30
10758750008322VITROS100940610094062020-04-08
10758750002061VITROS680215668021562015-12-22
10758750002504VITROS680230168023012015-12-22
10758750035366VITROS619945461994542025-05-20
10758750035373VITROS619945561994552025-05-20
10758750035380VITROS619945661994562025-05-20
20758750035363VITROS619945461994542025-05-20
20758750035370VITROS619945561994552025-05-20
20758750035387VITROS619945661994562025-05-20
10758750000203VITROS189683618968362016-08-26
10758750002801VITROS680245468024542014-10-22
10758750035465VITROS617444261744422023-11-22
10758750034420VITROS619996161999612021-11-08
10758750033355VITROS619991961999192021-03-22
10758750033362VITROS619992061999202021-03-22

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
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