FDA.reportPublic FDA data

Mercodia Insulin ELISA 10 pack

Primary DI
07350108630030
Brand
Mercodia Insulin ELISA 10 pack
Company
Mercodia AB
Model
10-1113-10
Catalog number
10-1113-10
Device description
Mercodia Insulin ELISA provides a method for the quantitative determination of human insulinin serum or plasma.
Published
2020-04-08
Public version status
New
Distribution status
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
07350108630030PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07350108630030073501086300307350108630030

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
07350108630047Insulin ELISA Kit (DAKO)K2379K23792020-04-08
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
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
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B24280INSHUUE010ALPCO Ultrasensitive Insulin ELISAAMERICAN LABORATORY PRODUCTS COMPANY, LTD.CFP2020-09-25
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00630414466187ADVIA Centaur® IRI DILSiemens Healthcare Diagnostics Inc.CFP2020-09-24
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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
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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