FDA.reportPublic FDA data

ARCHITECT

Primary DI
00380740156015
Brand
ARCHITECT
Company
Abbott GmbH
Model
03L5327
Catalog number
03L5327
Device description
ARCHITECT C-Peptide Reagent Kit
Published
2020-03-03
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

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
00380740156015PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00380740156015003807401560153807401560150380740156015

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

Contacts#

Phone, Email table
PhoneEmail
+1(877)422-2688xx@xx.xx

Regulatory Flags#

DUNS number
315786293
Device count
1
Premarket exempt
true
Kit
true
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00380740186173Alinity04T971A04T971A2026-10-15
00380740186180Alinity04T973A04T973A2026-10-15
00380740186197Alinity04T975A04T975A2026-10-15
00380740150662Alinity09P562009P56202019-06-27
00380740150679Alinity09P572009P57202019-06-27
00380740150693Alinity09P632009P63202019-07-08
00380740153922Alinity09P622009P62202019-12-24
00380740199265Alinity06T790106T79012026-09-04
00380740199272Alinity06T791006T79102026-09-04
00380740208899Alinity06T792106T79212026-09-04
00380740208905Alinity06T793106T79312026-09-04
00380740223724Alinity06T793A06T793A2026-09-04
00380740132552Alinity09P842009P84202023-11-16
00380740208622ARCHITECT4P52-2204P52222026-05-15
00380740208639Alinity08P432108P43212026-05-15
00380740193645ARCHITECT1P31-2701P31272026-04-28
00380740117207Alinity06P066006P06602019-10-12
00380740167455Alinity06P060306P06032019-10-12
00380740167462Alinity06P062006P06202019-10-12
00380740167479Alinity06P062406P06242019-10-12

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
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