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, Immunoreactive Insulin (CFP) (5) Radioimmunoassay, C-Peptides Of Proinsulin (JKD) (2) Apolipoproteins (MSJ) (1) Multi-Analyte Controls Unassayed (OHQ) (1) System, Test, Low Density, Lipoprotein (MRR) (1)

Premarket Exempt

Yes

Clear

Mercodia Lp(a) ELISA - 07350108630016 Catalog Number : 10-1106-01

Device Description : Mercodia Lp(a) ELISA provides a method for the quantitative determination of hum Mercodia Lp(a) ELISA provides a method for the quantitative determination of human Lp(a) inserum or plasma.

Device Class : 1

Duns Number: 354553091

Premarket Exempt : Yes

Product Code : MSJ

Prescription Use : No

Device Count : 1

Mercodia Insulin ELISA - 07350108630023 Catalog Number : 10-1113-01

Device Description : Mercodia Insulin ELISA provides a method for the quantitative determination of h Mercodia Insulin ELISA provides a method for the quantitative determination of human insulinin serum or plasma.

Device Class : 1

Duns Number: 354553091

Premarket Exempt : Yes

Product Code : CFP

Prescription Use : No

Device Count : 1

Mercodia Insulin ELISA 10 pack - 07350108630030 Catalog Number : 10-1113-10

Device Class : 1

Duns Number: 354553091

Premarket Exempt : Yes

Product Code : CFP

Prescription Use : No

Device Count : 1

Insulin ELISA Kit (DAKO) - 07350108630047 Catalog Number : K2379

Device Description : Insulin ELISA Kit provides a method for the quantitative determination of human 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.

Device Class : 1

Duns Number: 354553091

Premarket Exempt : Yes

Product Code : CFP

Prescription Use : No

Device Count : 1

Mercodia Iso-Insulin ELISA - 07350108630054 Catalog Number : 10-1128-01

Device Description : Mercodia Iso-Insulin ELISA provides a method for the quantitative determination Mercodia Iso-Insulin ELISA provides a method for the quantitative determination of insulin in human serum or plasma.

Device Class : 1

Duns Number: 354553091

Premarket Exempt : Yes

Product Code : CFP

Prescription Use : No

Device Count : 1

Mercodia Ultrasensitive Insulin ELISA - 07350108630061 Catalog Number : 10-1132-01

Device Description : Mercodia Ultrasensitive Insulin ELISA provides a method for the quantitative det Mercodia Ultrasensitive Insulin ELISA provides a method for the quantitative determination of insulin in human serum or plasma.

Device Class : 1

Duns Number: 354553091

Premarket Exempt : Yes

Product Code : CFP

Prescription Use : No

Device Count : 1

Diabetes Antigen Control (Unassayed) - 07350108630078 Catalog Number : 10-1134-01

Device Description : Mercodia Diabetes Antigen Control is designed to be used as a two-level control Mercodia Diabetes Antigen Control is designed to be used as a two-level control for human insulin, C-peptide and proinsulin. It is manufactured from human serum and human insulin, C-peptide and proinsulin.

Device Class : 1

Duns Number: 354553091

Premarket Exempt : Yes

Product Code : OHQ

Prescription Use : No

Device Count : 1

Mercodia C-peptide ELISA - 07350108630085 Catalog Number : 10-1136-01

Device Description : Mercodia C-peptide ELISA provides a method for the quantitative determination of Mercodia C-peptide ELISA provides a method for the quantitative determination of human C-peptide in serum, plasma or urine.

Device Class : 1

Duns Number: 354553091

Premarket Exempt : Yes

Product Code : JKD

Prescription Use : No

Device Count : 1

Mercodia Ultrasensitive C-peptide ELISA - 07350108630092 Catalog Number : 10-1141-01

Device Description : Mercodia Ultrasensitive C-peptide ELISA provides a method for the quantitative d Mercodia Ultrasensitive C-peptide ELISA provides a method for the quantitative determinationof human C-peptide in serum, plasma or urine.

Device Class : 1

Duns Number: 354553091

Premarket Exempt : Yes

Product Code : JKD

Prescription Use : No

Device Count : 1

Mercodia Oxidized LDL ELISA - 07350108630108 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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