FDA.reportPublic FDA data

STELLUX® Chemi Human Total Proinsulin ELISA

Primary DI
B24280PINHUTCH010
Brand
STELLUX® Chemi Human Total Proinsulin ELISA
Company
AMERICAN LABORATORY PRODUCTS COMPANY, LTD.
Model
80-PINHUT-CH01
Catalog number
80-PINHUT-CH01
Device description
The Proinsulin (Total) Chemiluminescence ELISA is designed for the quantitative determination of proinsulin in human serum, plasma (EDTA and heparin), and tissue culture supernatants. For in vitro diagnostic use.
Published
2020-07-17
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
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
B24280PINHUTCH010PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Proinsulin IVD, kit, enzyme immunoassay (EIA)A collection of reagents and other associated materials intended to be used for the quantitative measurement of proinsulin in a clinical specimen, using an enzyme immunoassay (EIA) 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
800.592.5726cs@alpco.com

Regulatory Flags#

DUNS number
784143778
Device count
1
Premarket exempt
true
Kit
true
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

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B24280EZEX21000Easy 2 Stool Extraction Device80-EZEX2-10080-EZEX2-1002025-10-30
B24280CALPHUCH500ALPCO Calprotectin Chemiluminescence ELISA80-CALPHU-CH5080-CALPHU-CH502019-11-04
B24224MABHUE010Microalbumin ELISA24-MABHU-E0124-MABHU-E012018-01-16
B24280LACHUFCSET0Lactoferrin CLIA Re-Calibrator and Control Set80-LACHU-FCSET2025-06-06
B24280PANHUFCSET0Pancreatic Elastase CLIA Re-Calibrator and Control Set80-PANHU-FCSET2025-06-06
B24225TT4HUE010Total Thyroxine ELISA (Total T4 ELISA)25-TT4HU-E0125-TT4HU-E012017-08-03
B24211PREHUE010Pregnenolone ELISA11-PREHU-E0111-PREHU-E012020-09-25
B24280PANHUCH500Pancreatic Elastase Chemiluminescence ELISA80-PANHU-CH5080-PANHU-CH502022-09-09
B24280LACHUFC1000ALPCO Lactoferrin CLIA Kit80-LACHU-FC10080-LACHU-FC1002025-03-03
B24211HGHHUE010Human Growth Hormone ELISA11-HGHHU-E0111-HGHHU-E012025-01-20
B24280PANHUFC1000ALPCO Pancreatic Elastase CLIA80-PANHU-FC10080-PANHU-FC1002024-07-25
B24280PANHUCH010Pancreatic Elastase Chemiluminescence ELISA80-PANHU-CH0180-PANHU-CH012022-09-09
B24211GLUHUE010Glucagon ELISA11-GLUHU-E0111-GLUHU-E012024-10-23
B24220TT3HUE011Total Triiodothyronine (Total T3) ELISA20-TT3HU-E0120-TT3HU-E012024-07-22
B24280CALPHUIT2000ALPCO Calprotectin Immunoturbidimetric Assay80-CALPHU-IT20080-CALPHU-IT2002023-08-18
B24280CALPHUITCAL0Calprotectin Immunoturbidimetric Assay - Calibrators80-CALPHU-ITCAL80-CALPHU-ITCAL2023-08-18
B24280CALPHUITCON0ALPCO Calprotectin Immunoturbidimetric Assay80-CALPHU-ITCON80-CALPHU-ITCON2023-08-18

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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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
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