FDA.reportPublic FDA data

Mercodia Oxidized LDL ELISA

Primary DI
07350108630108
Brand
Mercodia Oxidized LDL ELISA
Company
Mercodia AB
Model
10-1143-01
Catalog number
10-1143-01
Device description
The Mercodia Oxidized LDL ELISA kit is intended to be used for the in vitro quantitative measurement of oxidized low density lipoproteins (oxidized LDL) in human serum or plasma. Lipoprotein measurements are used in the diagnosis and treatment of lipid disorders (such as diabetes mellitus), atherosclerosis, and various liver and renal diseases.
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
MRRSystem, Test, Low Density, Lipoprotein

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MRRSystem, Test, Low Density, LipoproteinClinical Chemistry1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
07350108630108PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07350108630108073501086301087350108630108

GMDN Terms#

Term, Definition table
TermDefinition
Oxidized low density lipoprotein (OxLDL) IVD, kit, enzyme immunoassay (EIA)A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of oxidized low density lipoprotein (OxLDL) in a clinical specimen, using an enzyme immunoassay (EIA) method. It is typically used in the diagnosis and treatment of lipid disorders (such as diabetes mellitus), atherosclerosis, and various liver and renal diseases.

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
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

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