Mercodia AB

Address:SYLVENIUSGATAN 8A,UPPSALA,SE

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Device Class

Class-1 (A medical device with low to moderate risk that requires general controls) Class-2 (A medical device with a moderate to high risk that requires special controls) Class-3 (A medical device with high risk that requires premarket approval) Class-U (Unclassified)

Product Code

Radioimmunoassay, Glucagon (JME) (2) System, Test, Low Density, Lipoprotein (MRR) (1)

Premarket Exempt

Yes

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Mercodia Glucagon ELISA - 07350108630115 Catalog Number : 10-1271-01

Device Description : Mercodia Glucagon ELISA is an assay intended to measure the pancreatic hormone g Mercodia Glucagon ELISA is an assay intended to measure the pancreatic hormone glucagon inplasma and serum. Glucagon measurements are used in the diagnosis and treatment of patientswith various disorders of carbohydrate metabolism, including diabetes mellitus, hypoglycemia,and hyperglycemia.

Device Class : 1

Duns Number: 354553091

Premarket Exempt : Yes

Product Code : JME

Prescription Use : No

Device Count : 1

Mercodia Glucagon ELISA - 07350108630122 Catalog Number : 10-1271-01

Device Class : 1

Duns Number: 354553091

Premarket Exempt : Yes

Product Code : JME

Prescription Use : No

Device Count : 1

Mercodia Oxidized LDL ELISA - 07350108630139 Catalog Number : 10-1143-01

Device Description : The Mercodia Oxidized LDL ELISA kit is intended to be used for the in vitro quan 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.

Device Class : 1

Duns Number: 354553091

Premarket Exempt : Yes

Product Code : MRR

Prescription Use : No

Device Count : 1

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