FDA.reportPublic FDA data

Insulin ELISA Kit (DAKO)

Primary DI
07350108630047
Brand
Insulin ELISA Kit (DAKO)
Company
Mercodia AB
Model
K2379
Catalog number
K2379
Device description
Insulin ELISA Kit provides a method for the quantitative determination of human insulin inserum or plasma.As with all diagnostic tests, a definitve clinical diagnosis should not be based on the results of asingle test, but should be made by the physician after all clinical findings have been evaluated.The analysis should be performed by trained laboratory professionals.
Published
2020-04-08
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
CFPRadioimmunoassay, Immunoreactive Insulin

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
CFPRadioimmunoassay, Immunoreactive InsulinClinical Chemistry1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
07350108630047PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07350108630047073501086300477350108630047

GMDN Terms#

Term, Definition table
TermDefinition
Insulin IVD, kit, enzyme immunoassay (EIA)A collection of reagents and other associated materials intended to be used for the quantitative measurement of insulin 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
+4618570070info@mercodia.com

Regulatory Flags#

DUNS number
354553091
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
07350108630078Diabetes Antigen Control (Unassayed)10-1134-0110-1134-012020-04-08
07350108630108Mercodia Oxidized LDL ELISA10-1143-0110-1143-012020-04-08
07350108630115Mercodia Glucagon ELISA10-1271-0110-1271-012020-04-08
07350108630139Mercodia Oxidized LDL ELISA10-1143-0110-1143-012021-09-01
07350108630122Mercodia Glucagon ELISA10-1271-0110-1271-012020-10-01
07350108630016Mercodia Lp(a) ELISA10-1106-0110-1106-012020-04-08
07350108630023Mercodia Insulin ELISA10-1113-0110-1113-012020-04-08
07350108630030Mercodia Insulin ELISA 10 pack10-1113-1010-1113-102020-04-08
07350108630054Mercodia Iso-Insulin ELISA10-1128-0110-1128-012020-04-08
07350108630061Mercodia Ultrasensitive Insulin ELISA10-1132-0110-1132-012020-04-08
07350108630085Mercodia C-peptide ELISA10-1136-0110-1136-012020-04-08
07350108630092Mercodia Ultrasensitive C-peptide ELISA10-1141-0110-1141-012020-04-08

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00850049545723AccuDiag™ Insulin ELISADiagnostic Automation, Inc.CFP2026-01-27
00859410006269SalimetricsSALIMETRICS, LLCCFP2024-09-18
00859410006276SalimetricsSALIMETRICS, LLCCFP2024-09-18
04048474053616InsulinDRG Instruments Gesellschaft mit beschränkter HaftungCFP2023-09-01
04048474036084Anti-Insulin ELISADRG Instruments Gesellschaft mit beschränkter HaftungCFP2023-08-31
04048474029352Insulin ELISADRG Instruments Gesellschaft mit beschränkter HaftungCFP2023-08-29
00840239053619InsulinDRG International IncCFP2023-08-26
00840239036087Anti-Insulin ELISADRG International IncCFP2023-08-25
00840239029355Insulin ELISADRG International IncCFP2023-08-24
06925912718871iFlash-InsulinShenzhen YHLO Biotech Co., Ltd.CFP2022-10-26
00404847429350Insulin ELISADRG Instruments Gesellschaft mit beschränkter HaftungCFP2021-06-07
00404847436082Anti-Insulin ELISADRG Instruments Gesellschaft mit beschränkter HaftungCFP2021-06-07
00404847453614InsulinDRG Instruments Gesellschaft mit beschränkter HaftungCFP2021-06-07
B24280INSHUCH100STELLUX® Chemi Human Insulin ELISA JumboAMERICAN LABORATORY PRODUCTS COMPANY, LTD.CFP2020-09-25
B24280INSHUE010ALPCO Insulin ELISAAMERICAN LABORATORY PRODUCTS COMPANY, LTD.CFP2020-09-25
B24280INSHUE100ALPCO Insulin ELISA JumboAMERICAN LABORATORY PRODUCTS COMPANY, LTD.CFP2020-09-25
B24280INSHUUE010ALPCO Ultrasensitive Insulin ELISAAMERICAN LABORATORY PRODUCTS COMPANY, LTD.CFP2020-09-25
B24280INSHUUE100ALPCO Ultrasensitive Insulin ELISA JumboAMERICAN LABORATORY PRODUCTS COMPANY, LTD.CFP2020-09-25
00630414461021ADVIA Centaur® IRISiemens Healthcare Diagnostics Inc.CFP2020-09-24
00630414466187ADVIA Centaur® IRI DILSiemens Healthcare Diagnostics Inc.CFP2020-09-24
00630414466200ADVIA Centaur® IRISiemens Healthcare Diagnostics Inc.CFP2020-09-24
00630414600444Atellica IM IRISiemens Healthcare Diagnostics Inc.CFP2020-09-24
00630414600468Atellica IM IRI DILSiemens Healthcare Diagnostics Inc.CFP2020-09-24
00630414600475Atellica IM IRI DILSiemens Healthcare Diagnostics Inc.CFP2020-09-24
00630414954028IMMULITE®/IMMULITE® Systems 1000 Systems INS Insulin Sample DiluentSIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTDCFP2020-09-24
00630414966014IMMULITE® 2000 Systems INS InsulinSIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTDCFP2020-09-24
00630414966045IMMULITE® 2000 Systems INS InsulinSIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTDCFP2020-09-24
00630414966243IMMULITE®/IMMULITE® 1000 Systems INS InsulinSIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTDCFP2020-09-24
00630414998954IMMULITE® INS Control InsulinSIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTDCFP2020-09-24
B24280INSHUCH010STELLUX® Chemi Human Insulin ELISAAMERICAN LABORATORY PRODUCTS COMPANY, LTD.CFP2020-07-17