Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3001431095

FEI Number

3001431095

Entity Name

SERO AS

City/State/Country

Billingstad Oslo, NO

Establishment Address

Stasjonsveien 44, Billingstad Oslo 1396, NO

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

SERO AS (Owner Number: 10085389)

Owner / Operator Contact Address

Stasjonsveien 44, Billingstad, NO-03 1396, NO

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Seronorm Trace Elements Whole Blood L-3 Seronorm Trace Elements Serum L-2 Seronorm Trace Elements Urine L-2 Seronorm Trace Elements Urine L-1 Seronorm Trace Elements Whole Blood L-2 Seronorm Trace Elements Whole Blood L-1 Seronorm Trace Elements Serum L-1 Seronorm Immunoprotein Liq L-2 Pathonorm Cardiac Acute Liq L-1 Seronorm Cardiac Acute Liq L-1A Seronorm Human Seronorm Cardiac Acute Liq L-1B Seronorm Urine L-2 Seronorm Urine L-1 Seronorm Cardiac Acute Liq L-2 Seronorm Immunoprotein Lyo L-1 Seronorm Cardiac Acute Liq L-3 Seronorm Human High Autonorm Clinical Chemistry Liq L-1 Seronorm Immunoprotein Liq L-1 Autonorm Clinical Chemistry Liq L-2 Autonorm Clinical Chemistry Liq L-3 Seronorm Immunoprotein Lyo L-2 Pathonorm Cardiac Acute Liq L-2 Autonorm Pathonorm Cardiac Acute Liq L-3 Pathonorm Calibration Verification Set TnI L-E Pathonorm Calibration Verification Set TnI L-B Pathonorm Calibration Verification Set TnI L-D Pathonorm Calibration Verification Set TnI Pathonorm Calibration Verification Set TnI L-C Pathonorm Calibration Verification Set TnI L-A Autonorm Pharmaca Liq L-2 Autonorm Pharmaca Liq L-1

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
DIE	Heavy Metals Control Materials	Clinical Toxicology	Class 1	862.3280	2022-06-13
JJY	Multi-Analyte Controls, All Kinds (Assayed)	Clinical Chemistry	Class 1	862.1660	2022-06-13
DIF	Drug Mixture Control Materials	Clinical Toxicology	Class 1	862.3280	2022-06-13

Official Correspondent

Julie Qian

US Agent Details

Martin Dahlgaard Business: USA Denmark Law Email: martin.dahlgaard@usadenmarklaw.com Phone: (917) 7191088

Related Public Records

Same Entity

SERO AS

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

View Entity Profile →

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K990531	Ortho-Clinical Diagnostics, Inc.	VITROS IMMUNODIAGNOSTIC PRODUCTS ONCOLOGY CONTROLS	1999-03-12
K982637	Diagnostic Products Corp.	IMMULITE PSA CONTROL MODULE, MODEL LPSCM	1998-08-12
K012468	Dade Behring, Inc.	MODIFICATION TO N/T PROTEIN CONTROL SL	2001-09-04
K803039	General Diagnostics	PROFILE ANTI-CONVUL. SET ASSAYED S. CTL.	1980-12-22

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3002642396	Ortho Clinical Diagnostics	Singapore South West, SG
2050010	BECKMAN COULTER, INC.	CARLSBAD, CA, US

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3001431095. Last updated year: 2026. Please use registration number 3001431095 when referencing this establishment in official correspondence.