Invicon Diagnostic Concepts

What Invicon Diagnostic Concepts does

Invicon Diagnostic Concepts GmbH is a privately held German manufacturer and distributor of third-party quality control materials for clinical diagnostic laboratories, founded in 2005 and headquartered in Neuried near Munich. The company sells a portfolio of approximately 250 articles under its proprietary invitrol® brand and through exclusive DACH distribution agreements with SERO (Norway) for Seronorm controls and UTAK (USA) for toxicology and trace element controls, with additional distribution of Quantimetrix sweat controls for cystic fibrosis testing. Core products are lyophilized, serum-based controls for clinical chemistry, protein diagnostics, immunochemistry, drugs/TDM and trace elements, organized around a cost-saving multianalyte strategy in which roughly three controls cover approximately 95% of routine serum analytes.

The business is built on a field-sales GTM in which medical product consultants (including dedicated Key Account Managers such as Angelika Petzold) provide on-site consultation and use the proprietary Select Control tool to design individual QC concepts and annual needs assessments per laboratory. Distribution is direct from the Neuried/Munich headquarters with refrigerated and frozen shipping, no minimum order value, and standing-order and batch-reservation programs. The company has been ISO 13485 certified since 2007 (most recently renewed as TÜV-Süd ISO 13485:2025 Rev. 04) and holds Swiss IvDV registration, supporting ISO 15189 accreditation requirements of its laboratory customers.

Invicon serves approximately 800 medical diagnostic laboratories across Germany, Austria and Switzerland. The company remains founder-led (Hermann Borgel, biologist; Dr. Lydia Estermaier, PhD biochemist) with no disclosed institutional investors, no funding rounds, and no publicly disclosed revenue; pricing is unit-based with pay-as-you-go billing and shipping costs calculated per order depending on parcel size and temperature requirements.

Name

Invicon Diagnostic Concepts

Legal name

invicon diagnostic concepts GmbH

Website

https://invicon.de

Company type

Private

Founded year

2005

Operating status

Operating

Headcount range

11–50 employees

Short description

Invicon Diagnostic Concepts GmbH manufactures and distributes invitrol® and distributed third-party quality controls (Seronorm, UTAK) for clinical chemistry, immunochemistry and toxicology, serving about 800 diagnostic laboratories across Germany, Austria and Switzerland.

Ownership category

akta.pro rank

Product category

Clinical Diagnostic 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)

Keywords

• Clinical chemistry controls
• Quality control materials
• Immunochemistry diagnostics
• Toxicology controls
• Lyophilized serum controls

Headquarters

HQ city

Munich

HQ country

Germany

HQ region

Europe

Offices2 records

Markets served

GTM type

B2B

Offering type

Hardware or Manufacturing

Cost components

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

Revenue model

1. Quality Control Materials Sales: Sale of third-party quality control products including own invitrol brand controls and exclusive distribution products (Seronorm from SERO, UTAK products). Products cover clinical chemistry, protein diagnostics, immunochemistry, drugs/TDM, trace elements, sweat controls. Approximately 250 articles offered.
2. Custom QC Concept Services: Free consultation service creating individual control concepts for laboratories. Uses Select Control tool to calculate optimal control composition and annual needs, generating customer engagement and product sales.

Pricing tiers

Go-to-market motion2 records

Distribution channels2 records

Marketing channels3 records

Core offering

Invicon diagnostic concepts GmbH manufactures and distributes lyophilized, serum-based third-party quality control materials for medical laboratories, covering clinical chemistry, protein diagnostics, immunochemistry, toxicology/drug testing, trace element analysis, and sweat (cystic fibrosis) testing. The portfolio combines the proprietary invitrol® brand with exclusive distribution of SERO/Seronorm™, UTAK, and Quantimetrix products, totaling approximately 250 articles, and is delivered with a free Select Control consulting service for tailored control concepts.

Product overview

Invicon Diagnostic Concepts offers a unified portfolio of laboratory quality control products combining proprietary invitrol® branded controls with exclusive distribution products from SERO and UTAK. The core offering consists of third-party quality controls for clinical chemistry, protein diagnostics, and immunochemistry, using a cost-saving multianalyte strategy where just three control products cover approximately 95% of routine serum analytes. The product line includes: invitrol® Lipid (specialty lipid controls), invitrol® and Seronorm™ (for clinical chemistry and immunochemistry), UTAK products (for drugs, toxicology, and trace elements from various sample matrices), Quantimetrix Sweat Controls (for cystic fibrosis testing), Copper and Zinc System Reagents, and the Waterbath Disinfectant. The company also provides the Select Control service tool for optimizing control concepts. With approximately 250 articles serving around 800 customers, the portfolio is complemented by personalized consulting services.

Differentiator

Problem solved

Functional benefit

Brands

• invitrol®: Own brand of lyophilized, serum-based lipid controls for clinical chemistry quality control.
• Select Control

Products and services

• invitrol® Lipid Lyophilized, serum-based third-party lipid quality control with pathological Lp(a) values for clinical chemistry laboratories, offering long shelf life and ISO 15189-compatible independent quality assurance.
• invitrol® Immunoassay / Clinical Chemistry Controls Lyophilized, serum-based third-party quality controls for clinical chemistry, protein diagnostics and immunochemistry, designed to cover approximately 95% of routine serum analytes with only three control products under the multianalyte strategy.
• Seronorm™ Controls (SERO, Norway) Third-party quality controls for immunochemistry and clinical chemistry, distributed exclusively by invicon from SERO (Norway), equipped with analytical data determination and target values adapted for the German market with RiLiBÄK-compliant permitted ranges.
• UTAK Controls (Drugs, Toxicology, Trace Elements) Third-party quality control solutions for drugs, medicines, toxicology and trace elements from whole blood, serum, plasma, urine and saliva, distributed exclusively in DACH by invicon from UTAK (USA), including custom-made controls.
• Quantimetrix Sweat Control Set Three-level control set for monitoring and screening of sweat in cystic fibrosis testing, covering Chloride, Conductivity, Osmolarity, Potassium and Sodium, distributed by invicon from Quantimetrix.
• Copper System Reagent Clinical chemistry reagent for the determination of Copper, usable manually or as a system reagent adapted for ROCHE cobas and other analyzer systems.
• Zinc System Reagent Clinical chemistry reagent for the determination of Zinc, usable manually or as a system reagent adapted for ROCHE cobas Modular and Hitachi analyzers.
• Waterbath Disinfectant (Temperierbad Additiv) Disinfectant solution for laboratory water baths that inhibits bacteria, fungi and algae growth, prevents precipitation of inorganic salts and provides a contamination indicator via decolorization.

Quantifiable outcome

• 95% of routine serum analytes covered by just three control products
• +2 more outcomes

Named customers1 record

Segments2 records

Ideal customer profiles4 records

Technology focussed No

API detail

Has API

No

API docs

API detail

Core technology

AI maturity

App detail

Feature4 records

Partnerships

Three partnerships are on record, tiered core and minor.

• SERO (Norway)coreChannel Partner/ Reseller/ DistributorExclusive distribution partnership for Seronorm quality controls from SERO (Norway). invicon equips Seronorm controls via analytical data determination with target values specially adapted for the German market, optimized with RiLiBÄK-compliant permitted ranges.
• UTAK (USA)coreChannel Partner/ Reseller/ DistributorExclusive distribution partnership for UTAK products from USA, enabling QC solutions for drugs, medicines, toxicology and trace elements from whole blood, serum, plasma, urine and saliva. invicon distributes custom-made UTAK controls.
• QuantimetrixminorChannel Partner/ Reseller/ DistributorDistribution of Quantimetrix Sweat Control Set for cystic fibrosis testing. Three-level control set for monitoring and screening of sweat analytes including Chloride, Conductivity, Osmolarity, Potassium and Sodium.

Scale indicators5 records

Recent moves1 record

Expansion highlights5 records

Broad incumbents

• Bio-Rad Laboratories: Global leader in independent third-party quality controls (Liquichek, Lyphochek) for clinical chemistry and immunology. Directly competes with invicon in the same third-party QC category but at vastly greater scale and global reach, making it the most relevant incumbent peer.
• Thermo Fisher Scientific: Diversified life-sciences and diagnostics supplier (formerly part of Thermo; includes specialized QC and calibration verification offerings through its Clinical Diagnostics business). Broad incumbent operating across clinical chemistry controls, laboratory equipment and consumables.
• Roche Diagnostics: Manufacturer of cobas analyzers and corresponding on-board QC reagents. While primarily an analyzer/reagent vendor, Roche competes with independent QC suppliers by bundling controls with placement contracts and is a key reference customer for invicon's Cobas-compatible system reagents (Copper, Zinc).
• Siemens Healthineers: Global IVD platform vendor (Atellica, ADVIA Centaur) producing proprietary QC materials and broad menu of clinical chemistry/immunoassay reagents. Competes in QC through analyzer-bundled offerings and serves the same hospital laboratory customers as invicon.
• Abbott Diagnostics: Major IVD platform vendor (Alinity, Architect) with proprietary QC controls and reagents spanning clinical chemistry and immunoassay. Broad incumbent competing in QC partly through bundled placement, serving the same end-customers as invicon.

Direct peers

• Quantimetrix: US manufacturer of specialty QC controls including sweat controls for cystic fibrosis testing (distributed by invicon). Direct peer in specialty IVD QC manufacturing, especially in niche analytes such as sweat chloride/conductivity.
• Technopath Clinical Diagnostics: Ireland-based independent manufacturer of third-party QC and calibration verification materials (Multichem, IA+, TOX). Direct peer in third-party QC business model, with similar target customer of hospital and reference laboratories.
• SERO: Norwegian manufacturer of Seronorm quality controls and invicon's exclusive distribution partner. Despite the partnership, SERO is a direct peer manufacturing and selling clinical chemistry/immunochemistry QC, with overlapping product technology and customers.
• UTAK Laboratories: US manufacturer of QC products for drugs of abuse, toxicology and trace elements, and invicon's exclusive distribution partner. Peer in specialty QC manufacturing serving clinical and forensic toxicology laboratories.
• Randox Laboratories: Independent manufacturer of third-party QC materials (Acusera) covering clinical chemistry, immunoassay, and specialty analytes with multianalyte controls. Closely comparable to invicon in product concept, customer base, and lab-QC focus.

Market position

Strengths4 records

Weaknesses5 records

Competitive moat4 records

Key risks5 records

Key highlights6 records

Customer concentration

• LinkedInlinkedin.com/company/invicon-diagnostic-concepts-gmbh

Compliance2 records

Revenue estimate

Valuation estimate

Number of profiles

Profiles3 records

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 Invicon Diagnostic Concepts