SERO

What SERO does

SERO AS is a Norwegian manufacturer of independent quality control (QC) materials for medical laboratories, founded in 1963 by Professor Dr. med. Lorentz Eldjarn. The company produces lyophilized and liquid QC materials based primarily on human serum (containing more than 95% genuine serum without stabilizers or preservatives) under its Seronorm, Autonorm, and Pathonorm brands. Its portfolio spans clinical chemistry, immunoassay, immunoproteins, cardiac and acute markers, therapeutic drug monitoring, urine chemistry, trace elements (60+ elements), diabetes (HbA1c), and pediatric testing, with lot-specific analytical documentation produced by independent ISO 15189-accredited laboratories providing full traceability to international reference standards via ISO 17511. SERO also manufactures customized and white-label QC products under partner brands, including SERO Lumipulse for Fujirebio and Pathonorm Cardiac Acute for Siemens Healthineers, and is the Nordic distributor for Eiken Chemical's OC-Sensor fecal immunochemical and calprotectin systems.

SERO generates revenue through direct sales to hospitals and laboratories in the Nordic region (Norway, Sweden, Finland, Denmark) and through a network of independent distributors covering more than 60 countries, with dedicated partners in Japan (Sekisui, PropGene, Seishin Trading), Germany/Austria (Invicon), France (Eurobio Scientific), and Benelux (ELITechGroup). Its primary customers are clinical laboratories (hospital and reference labs) and IVD manufacturers — including top-ten IVD companies — who use SERO products for independent third-party QC, method comparison, instrument verification, and lot-to-lot consistency checks aligned with ISO 15189 requirements. All operations — R&D, raw material handling, accredited laboratory analysis, lyophilization, and logistics — are co-located at the ISO 13485-certified facility in Billingstad, Norway.

The company is privately held and has remained under family ownership since its founding (with Knut Eldjarn, son of the founder, serving as Chairman), with no external private equity or venture capital involvement disclosed. It operates a wholly-owned Chinese subsidiary, SERO BioScience & Technology (Beijing) Co., Ltd, established in 2016, produces more than 2 million vials annually, and exports more than 95% of its output.

Name

SERO

Legal name

SERO AS

Website

https://sero.no

Company type

Private

Founded year

1963

Operating status

Operating

Headcount range

11–50 employees

Short description

SERO AS is a Norwegian manufacturer founded in 1963 that produces independent, human-serum-based quality control materials for medical laboratories. It sells directly in the Nordics and through distributors in 60+ countries, and manufactures customized QC products for major IVD companies.

Ownership category

akta.pro rank

Product category

In Vitro Diagnostics Quality Control Materials

NAICS

In-Vitro Diagnostic Substance Manufacturing (325413), Medical Equipment and Supplies Manufacturing (3391)

SIC

In Vitro & In Vivo Diagnostic Substances (2835), Wholesale-Medical, Dental & Hospital Equipment & Supplies (5047)

akta.pro primary industry

Quality Control, Calibrators, Standards & Proficiency Testing (IVD Consumables) (HLAHAAAL)

akta.pro secondary industries

Release Testing & Batch Certification (QC) (HLAGADAC), Analytical Development & QC Testing (Release/Stability/Potency) (HLAGAGAF), Toxicology & Therapeutic Drug Monitoring Laboratories (HLAFAMAF), Impurity / Reference Standard Synthesis & Characterization (HLAGAHAG), Method Development & Validation (ICH/USP) (HLAGADAB)

Keywords

• Quality control materials
• Clinical chemistry controls
• Immunoassay controls
• Cardiac marker controls
• Trace element controls

Headquarters

HQ city

Sandvika

HQ country

Norway

HQ region

Europe

Offices1 record

Markets served

GTM type

B2B

Offering type

Hardware or Manufacturing

Cost components

Personnel, Supply Chain, Operations, Technology or R&D, Infrastructure, Marketing or Sales

Revenue model

1. QC Materials Sales: SERO generates revenue through the sale of quality control materials under the Seronorm and Autonorm brands. Products are sold directly to laboratories in Nordic countries and through distribution partners in over 60 countries worldwide.
2. Customized/Partner Branded Solutions: SERO offers white-label and customized QC products for IVD companies and partners, including regulatory market approvals (CE mark, FDA)
3. OC-Sensor Distribution: Distribution of OC-Sensor fecal immunochemical test systems and calprotectin testing products in Nordic countries for Eiken Chemical Co.

Go-to-market motion1 record

Distribution channels3 records

Marketing channels5 records

Core offering

SERO manufactures and supplies independent third-party quality control materials for medical laboratory diagnostics, sold under the Seronorm, Autonorm, and Pathonorm brands in both lyophilized (freeze-dried) and liquid human-serum-based formats. The QC portfolio covers clinical chemistry, immunoassay, cardiac and acute markers, immunoproteins, trace elements, therapeutic drug monitoring (TDM), HbA1c, urine, and pediatric analytes, with lot-specific analytical documentation produced by independent ISO 15189 accredited laboratories and traceability to international reference methods per ISO 17511.

Product overview

SERO is a manufacturer and supplier of independent quality control materials for medical laboratory diagnostics, offering a comprehensive portfolio of products under the Seronorm® and Autonorm® brands. The core product line includes liquid and lyophilized (freeze-dried) quality controls for immunoassay, clinical chemistry, cardiac/acute markers, immunoproteins, trace elements, therapeutic drug monitoring, diabetes (HbA1c), urine analysis, and pediatric testing. SERO's products are based on human serum and designed to provide accurate, commutable controls that mirror patient sample conditions. The company also distributes Eiken Chemical's OC-Sensor fecal testing systems in Nordic regions and offers customized manufacturing services for partner-branded solutions. All products feature lot-specific documentation with analytical data from independent ISO 15189-accredited laboratories.

Differentiator

Problem solved

Functional benefit

Brands

• SERO Maternal Health: Lyophilized human serum control for prenatal quality control manufactured under strict quality control standards
• SERO Lumipulse
• Pathonorm Cardiac Acute
• Pathonorm Calibration Verification Set TnI

Products and services

• Seronorm® Immunoassay Liq Liquid quality control integrating a broad spectrum of immunoassay analytes (hormones, cardiac markers, fertility, cancer markers) based on 100% human serum with extensive documentation for diverse instrument platforms; for clinical laboratories.
• Seronorm® Immunoassay Lyo Lyophilized immunoassay quality control with assigned values for over 55 analytes, based on human serum; for clinical laboratories needing extended shelf life and easy transport.
• Seronorm® Cardiac Acute Lyo Lyophilized QC designed for acute cardiac diagnostics, covering critical markers Troponin I, Troponin T, CK-MB, and Myoglobin with high lot-to-lot consistency and clinically relevant levels; for hospital and reference laboratories.
• Seronorm® Cardiac Acute Liq Liquid QC integrating a full panel of cardiac and acute markers (Troponin I, Troponin T, BNP, NT-proBNP, Procalcitonin, IL-6, D-dimer, S-100 beta) for swift diagnostics; for clinical laboratories.
• Seronorm® Immunoassay Liq Low Additional lower-level immunoassay control complementing Seronorm® Immunoassay with clinically relevant low levels of Aldosterone, Androstenedione, Cortisol, Ferritin, IgE, PSA total, free T4, TSH, and Vitamin D; for clinical laboratories.
• Seronorm® Immunoprotein Lyo Lyophilized QC containing over 20 crucial proteins including Cystatin C, anti-CCP, RF, CRP, Digitoxin, and ASL/ASO for comprehensive immunodiagnostic needs; for clinical laboratories.
• Seronorm® Immunoprotein Liq Liquid QC for comprehensive immunoprotein testing containing over 20 crucial proteins including Cystatin C, anti-CCP, RF, CRP, Digitoxin, and high CRP; for clinical laboratories.
• Autonorm® Clin Chem Liq Liquid clinical chemistry multi-analyte control including a broad spectrum of clinical chemistry analytes, lipids, enzymes, proteins, hormones, cardiac markers, therapeutic drugs, and bicarbonate at three clinically relevant levels; for clinical laboratories.
• Seronorm® Human Multi-component lyophilized QC crafted from human serum for precision across a wide range of analyses, covering over 45 analytes including lipids, routine clinical chemistry analytes, enzymes, proteins, cardiac markers, and therapeutic drugs; for clinical laboratories.
• Autonorm® Immunoassay Lyo Lyophilized immunoassay control with documentation customized for Beckman Coulter users, integrating a broad spectrum of immunoassay analytes including hormones, cardiac markers, fertility, and cancer markers; for clinical laboratories using Beckman Coulter platforms.
• Autonorm® Immunoassay Liq Liquid immunoassay control with documentation customized for Roche Cobas and Abbott platforms, integrating a broad spectrum of immunoassay markers including hormones, cardiac markers, fertility, and cancer markers; for clinical laboratories.
• Seronorm® Paediatric Specialized lyophilized accuracy control serum for newborn testing with high bilirubin levels, based on 100% human serum with comprehensive documentation for ALP and bilirubin analytes; for pediatric and hospital laboratories.
• Seronorm® Urine Liquid ready-to-use human urine QC for a wide range of analytes including albumin, creatinine, glucose, and electrolytes, with 31 days open vial stability; for clinical laboratories.
• Seronorm® CRP Liquid Liquid C-reactive protein QC ready from the fridge with five-year long-term stability, providing assigned values for laboratory and Point-of-Care instrumentation at three clinically relevant levels; for clinical laboratories.
• Seronorm® HbA1c Liquid Ethically produced HbA1c control for diabetic monitoring created via in-vitro glycation of human blood from healthy donors; liquid format ready to use immediately after thawing with extensive documentation for immunological and PoC methods; for clinical laboratories.
• Autonorm® Pharmaca Liq Liquid therapeutic drug monitoring control containing more than 20 drugs covering a wide range of therapeutic areas, based on 100% human serum without preservatives or stabilizers; for clinical laboratories.
• Seronorm® Trace Elements Whole Blood Quality control for trace elements analysis in whole blood with documented analytical values for over 60 elements at three clinically relevant levels for essential elements; for clinical laboratories.
• Seronorm® Trace Elements Urine Quality control for trace elements analysis in urine with documented analytical values for over 60 elements, based on 100% human urine free from preservatives and stabilizers; for clinical laboratories.
• Seronorm® Trace Elements Serum Quality control for trace elements analysis in serum with analytical values for over 60 elements, based on 100% human serum free from preservatives and stabilizers, with extended stability from lyophilized format; for clinical laboratories.
• SERO Maternal Health® Lyophilized human serum control manufactured under strict quality control standards to meet tailored needs of specific prenatal quality control; a customized SERO Branded Solution; for prenatal diagnostics laboratories.
• SERO Lumipulse Customized immunoassay control specifically developed for Fujirebio Inc. Lumipulse® instruments; multicontrol combining immunoassay, hormones, cardiac and cancer markers based on human serum; for IVD partners and their end-user laboratories.
• Pathonorm® Cardiac Acute Liquid frozen human serum QC for use as quality control to monitor immunoassay measurements on point-of-care Siemens Healthineers Atellica® VTLi systems; a customized partner-branded solution; for cardiac diagnostics.
• Pathonorm® Calibration Verification Set TnI Dedicated control for verifying the accuracy of the calibrated analytical measuring range of Troponin I, supporting quality assurance and instrument performance confirmation; for cardiac diagnostics laboratories.
• SERO Branded Solutions Customization service providing SERO's high-quality QC products customized to specific client needs (analytes, concentrations, and volumes) with option for regulatory market approvals in Europe (CE mark) and the US (FDA); for IVD companies.
• Partner Branded Solutions White-label / private-label QC product manufacturing service enabling IVD and partner companies to create unique control products under their own branding, customized by analyte, concentration, and volume; for IVD companies.
• RuO Trace Elements Serum / Whole Blood / Urine Controls Research Use Only versions of Seronorm Trace Elements Serum, Whole Blood, and Urine quality controls intended solely for research and development purposes, not approved for diagnostic or clinical procedures; for research laboratories.

Quantifiable outcome

• Producing over 2 million vials annually
• +3 more outcomes

Named customers4 records

Segments3 records

Ideal customer profiles2 records

Technology focussed No

API detail

Has API

No

API docs

API detail

Core technology

AI maturity

App detail

Feature4 records

Partnerships

Eleven partnerships are on record, tiered core, historical and major.

• Siemens HealthineerscoreChannel Partner/ Reseller/ Distributor · 1 January 2020Pathonorm Cardiac Acute is a liquid frozen human serum control specifically developed for Siemens Healthineers Atellica VTLi point-of-care systems for cardiac diagnostics.
• Eiken Chemical Co., Ltd.coreChannel Partner/ Reseller/ Distributor · 1 January 2006Agreement signed for distribution of Eiken's IFOBT products in Scandinavia.
• Nycomed (now part of Takeda)historicalStrategic or Co-development Partner · 1 January 1998Historical joint venture partnership from 1963 to 1998 for production and marketing of control sera products. SERO took full responsibility for the products in 1998.
• Eiken Chemical Co., Ltd.coreChannel Partner/ Reseller/ DistributorSERO is the Nordic distributor for OC-Sensor system by Eiken Chemical Co., offering advanced FIT testing for colorectal cancer screening and calprotectin testing for IBD diagnosis. The partnership includes OC-Sensor Pledia (high-throughput), OC-Sensor Ceres (compact), and OC-Auto Sampling bottles.
• Fujirebio Inc.coreChannel Partner/ Reseller/ DistributorSERO manufactures SERO Lumipulse, a specialized immunoassay control for Fujirebio Lumipulse instruments, combining immunoassay, hormones, cardiac and cancer markers based on human serum.
• Sekisui Medical Co., Ltd.majorChannel Partner/ Reseller/ DistributorJapanese distributor for Autonorm, Seronorm Human, Seronorm Human High, Seronorm CRP, and Autonorm Pharmaca products.
• PropGene Inc. (Japan)majorChannel Partner/ Reseller/ DistributorJapanese distributor for Autonorm Clin Chem, Seronorm Immunoassay, Seronorm Cardiac Acute, and Seronorm Immunoprotein.
• Seishin Trading Co., Ltd. (Japan)majorChannel Partner/ Reseller/ DistributorJapanese distributor for Seronorm Trace Elements product range and Seronorm Urine.
• Eurobio Scientific (France)majorChannel Partner/ Reseller/ DistributorFrench distributor for SERO quality control products.
• Invicon Diagnostic (Germany/Austria)majorChannel Partner/ Reseller/ DistributorGerman and Austrian distributor for SERO products, also providing additional analytical data for certain products in the German market.
• ELITechGroup (Benelux)majorChannel Partner/ Reseller/ DistributorBenelux distributor for SERO quality control products.

Scale indicators6 records

Recent moves7 records

Expansion highlights5 records

Broad incumbents

• Roche Diagnostics: Roche sells PreciControl and other proprietary QC consumables integrated with its Cobas instrument platform — overlapping with SERO's Autonorm Immunoassay Liq which is customized for Roche Cobas systems.
• Beckman Coulter: Beckman Coulter supplies proprietary controls for its DxI/Access immunoassay platforms; SERO's Autonorm Immunoassay Lyo is explicitly customized for Beckman Coulter users, placing it in direct overlap.
• Siemens Healthineers: Siemens supplies proprietary QC alongside its Atellica and ADVIA Centaur systems and is a SERO OEM partner via Pathonorm Cardiac Acute for Atellica VTLi — overlapping as both a customer and a broad incumbent competitor.
• Abbott Diagnostics: Abbott provides its own QC controls across Architect and Alinity platforms; SERO's Autonorm Immunoassay Liq is explicitly customized for Abbott systems, making Abbott both a partner-channel and competitive threat.

Direct peers

• Bio-Rad Laboratories: Bio-Rad's Clinical Diagnostics division (including its Unity Real Time and InteliQ QC programs) is the largest global independent QC materials provider and the most direct competitor to SERO's Seronorm and Autonorm product lines across clinical chemistry and immunoassay.
• Maine Molecular Quality Controls (MMQC): MMQC produces independent quality controls and verification materials for molecular diagnostics and clinical chemistry, sharing SERO's positioning as a niche, specialist independent QC manufacturer serving hospital labs.
• Technopath Clinical Diagnostics: Technopath manufactures multi-analyte QC materials and is a specialist independent QC vendor for clinical chemistry and immunoassay, competing head-to-head with SERO in the third-party IVD controls segment.
• Randox Laboratories: Randox offers Acusera third-party QC materials spanning clinical chemistry, immunoassay, and therapeutic drug monitoring, directly competing with SERO's commutable human-serum-based portfolio across hospitals and reference labs.

Emerging players

• Eiken Chemical Co., Ltd. Eiken Chemical is both SERO's Nordic distribution partner for OC-Sensor fecal immunochemical testing and a Japan-based IVD reagent manufacturer expanding its own QC portfolio — an adjacent player with overlapping channel and reagent scope.
• Fujirebio Inc. Fujirebio is a specialty immunoassay manufacturer and SERO partner for the customized SERO Lumipulse control, with overlapping reach in hormones, cardiac, and cancer marker diagnostics.

Market position

Strengths5 records

Weaknesses5 records

Competitive moat6 records

Key risks5 records

Key highlights7 records

Customer concentration

• LinkedInlinkedin.com/company/sero-as
• Facebookfacebook.com/profile.php

Compliance2 records

Revenue estimate

Valuation estimate

Number of profiles

Profiles2 records

Subsidiaries1 record

Funding overview

Funding rounds

Investors

Funding detail is available on the Subscription and Enterprise plan.Contact sales →

M&A

Investments

M&A and investment is available on the Subscription and Enterprise plan.Contact sales →

Frequently asked questions about SERO