Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3003356736

FEI Number

3003356736

Entity Name

MERCODIA AB

City/State/Country

UPPSALA, SE

Establishment Address

SYLVENIUSGATAN 8A, UPPSALA SE-754 50, SE

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

MERCODIA AB (Owner Number: 9028810)

Owner / Operator Contact Address

SYLVENIUSGATAN 8A, --, UPPSALA, SE-NOTA SE-754 50, SE

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Oxidized LDL ELISA Ultra Sensitive C-peptide ELISA C-peptide ELISA Mercodia Glucagon ELISA Iso-Insulin ELISA Insulin ELISA Ultra Sensitive Insulin ELISA INSULIN(MULTIPLE D Lp(a) ELISA Mercodia Diabetes Antigen Control

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
MRR	System, Test, Low Density, Lipoprotein	Clinical Chemistry	Class 1	862.1475	2003-01-22
JKD	Radioimmunoassay, C-Peptides Of Proinsulin	Clinical Chemistry	Class 1	862.1135	2003-01-22
JME	Radioimmunoassay, Glucagon	Clinical Chemistry	Class 1	862.1335	2016-09-27
CFP	Radioimmunoassay, Immunoreactive Insulin	Clinical Chemistry	Class 1	862.1405	1996-12-05
MSJ	Apolipoproteins	Clinical Chemistry	Class 1	862.1475	2003-01-22
OHQ	Multi-Analyte Controls Unassayed	Clinical Chemistry	Class 1	862.1660	2008-02-26

Official Correspondent

No official correspondent registered.

US Agent Details

Conor Wainwright Email: conor.wainwright@mercodia.com Phone: (336) 3912104

Related Public Records

Same Entity

MERCODIA AB

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0006-2009	Roche Diagnostics Corp.	1	Roche Diagnostics LDL_C, LDL- Cholesterol Plus 2nd generation, COBAS INTEGRA, cobas c systems, Roche Diagnostics, Indianapolis, IN.; 03038866322. An in-vitro diagnostic reagent system intended for use on COBAS Integra systems for the quantitative determination of LDL-Cholesterol concentrations in serum and plasma.

Similar Registrations

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9610529	ROCHE DIAGNOSTICS GMBH	PENZBERG Bavaria, DE
1827821	HORIBA INSTRUMENTS INCORPORATED	Canton, MI, US
1319808	ORTHO-CLINICAL DIAGNOSTICS, INC.	Rochester, NY, US
2247288	ALFA WASSERMANN	West Caldwell, NJ, US

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3003356736. Last updated year: 2026. Please use registration number 3003356736 when referencing this establishment in official correspondence.