Immundiagnostik

What Immundiagnostik does

Immundiagnostik, Inc. is the North American subsidiary of Immundiagnostik AG, a German specialty diagnostics company founded in 1986 in Bensheim. Established in Manchester, New Hampshire in 2018 by founder Franz Paul Armbruster and Karl Florian Wintgens alongside co-founders Jen Brock and Terry Fisher, the subsidiary distributes the parent company's IDK-branded immunoassay products across the United States and Canada. The company's products are trusted by laboratories in more than 70 countries worldwide through the broader Immundiagnostik AG and IDK Network ecosystem.

The company's product portfolio centers on enzyme-linked immunosorbent assays (ELISA), chemiluminescence immunoassays (CLIA), and liquid chromatography-tandem mass spectrometry (LC-MS/MS) methods. Proprietary technologies include sandwich ELISA techniques for biomarker measurement (e.g., oxidized LDL), competitive EIA with monoclonal antibodies (e.g., 1,25-dihydroxy vitamin D), solid-phase extraction combined with tandem mass spectrometry (e.g., hepcidin-25), the ImmuTube immunoaffinity enrichment platform for LC-MS/MS vitamin D testing, and the IDK Extract stool collection system. In October 2025, Immundiagnostik launched the ECL100 chemiluminescent immunoassay analyzer through a strategic partnership with Epitope Diagnostics, granting access to over 50 CLIA test kits with throughput of 120-180 tests per hour on a single-technician-operated benchtop platform. Products span 12+ therapeutic areas including cardiovascular and renal, gastrointestinal, immunology, bone and mineral metabolism, oncology, anemia, and therapeutic drug monitoring for anti-TNF biologics.

Revenue is generated through a sales-led go-to-market model targeting clinical diagnostic laboratories, research institutions, contract research organizations, and reference labs. Streams include one-time immunoassay kit sales ($350-$1,295 per kit), instrument sales (ECL100 analyzer, StatMatic I microplate washer), validation assistance services, custom bulk packaging with volume discounts, and proficiency testing programs for esoteric tests. Distribution occurs through direct e-commerce on idkna.com, a regional sales team including a National Sales Director and Regional Sales Directors, and technical applications scientists providing on-site training and remote support. Select products hold FDA Class 1 Exempt status; a separate Health Canada Licensed product line supports Canadian market entry.

Name

Immundiagnostik

Legal name

Immundiagnostik, Inc.

Website

https://idkna.com

Company type

Private

Founded year

2018

Operating status

Operating

Headcount range

1–10 employees

Short description

Immundiagnostik, Inc. is the North American subsidiary of Germany's Immundiagnostik AG, developing and distributing ELISA, CLIA, and LC-MS/MS immunoassay kits and the ECL100 automated analyzer for clinical and research laboratories across the US and Canada.

Ownership category

akta.pro rank

Product category

Clinical Laboratory Immunoassay Diagnostics

NAICS

In-Vitro Diagnostic Substance Manufacturing (325413), Analytical Laboratory Instrument Manufacturing (334516), Medical Equipment and Supplies Manufacturing (3391)

SIC

In Vitro & In Vivo Diagnostic Substances (2835), Laboratory Analytical Instruments (3826), Wholesale-Medical, Dental & Hospital Equipment & Supplies (5047)

akta.pro primary industry

IVD Reagents, Assay Kits & Consumables (Non-instrument) (HLAHAAAM)

akta.pro secondary industries

Immunoassay Diagnostics (ELISA, chemiluminescence, serology) (HLAAALAB), Reagents, Chemicals & Assay Kits (Buffers, Antibodies, ELISA, Enzymes) (HLAGAIAI), Biomarker Assay & Reagent Development (LDT/IVD assay design, antibodies/standards/controls) (HLAAAMAL), Clinical Chemistry & Immunoassay Systems (HLAHAAAA)

Keywords

• Immunoassay kits
• Clinical diagnostics
• ELISA assays
• Laboratory instruments
• Diagnostic reagents

Headquarters

HQ city

Manchester

HQ country

United States

HQ region

North America

Offices2 records

Markets served

GTM type

B2B

Offering type

Hardware or Manufacturing

Cost components

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

Revenue model

1. Immunoassay Kit Sales: Sale of ELISA, CLIA, and LC-MS/MS assay kits to clinical and research laboratories. Products are sold directly through the website with pricing ranging from approximately $350 to $1,295 per kit depending on assay type and format (bulk packs available).
2. Instrument Sales: Sales of laboratory instruments including the ECL100 Chemiluminescent Analyzer and StatMatic I Microplate Washer. Instruments enable labs to run CLIA tests with compatible reagents.
3. Validation Assistance Services: Fee-for-service technical support including assay validation assistance, on-site training, and ongoing remote support for laboratory validation projects.
4. Custom Bulk Packaging: Customized bulk packaging services for high-volume laboratories, including lot sequestration and inventory management, offering volume discounts and cost savings.
5. Proficiency Testing Services: Proficiency testing services for esoteric tests, providing interlaboratory data comparison with closing dates in March and October annually.

Pricing tiers

Go-to-market motion1 record

Distribution channels4 records

Marketing channels7 records

Core offering

Immundiagnostik develops, manufactures, and distributes immunoassay kits (ELISA, CLIA, LC-MS/MS), laboratory instruments (ECL100 Chemiluminescent Analyzer, StatMatic I Microplate Washer), and specialty sample collection systems (IDK Extract stool tubes, EasySampler kits) for clinical diagnostic and research laboratories across North America. The company also offers validation assistance services, custom bulk packaging, and proficiency testing for esoteric biomarkers spanning cardiovascular, gastrointestinal, immunology, oncology, bone health, anemia, and therapeutic drug monitoring categories.

Product overview

Immundiagnostik is a specialty diagnostics company offering a portfolio of enzyme immunoassay (ELISA) and chemiluminescence immunoassay (CLIA) products for clinical and research applications. The product portfolio centers on the ECL100 Chemiluminescent Immunoassay Analyzer (launched October 2025 via partnership with Epitope Diagnostics, Inc.) and a comprehensive line of over 50 CLIA test kits, alongside an established catalog of manual ELISA kits including Oxidized LDL ELISA, 1,25 (OH)2 Vitamin D ELISA, IDK® EDN ELISA, HERO ELISA, and Gluten Fecal ELISA. Products span diagnostic categories including Anemia, Bone & Mineral Metabolism, Cardiovascular & Renal, Gastrointestinal, Immunology, and Therapeutic Drug Monitoring. The company holds FDA Class 1 Exempt status for select products and offers Health Canada Licensed variants.

Differentiator

Problem solved

Functional benefit

Brands

• IDKmonitor®: Therapeutic drug monitoring assay brand for measuring drug levels and antibodies against biologics (e.g., Adalimumab, Etanercept, Golimumab, Infliximab).
• ReFiNE®
• IDK Extract®
• ECL100

Products and services

• ECL100 Chemiluminescent Immunoassay Analyzer Automated benchtop chemiluminescence immunoassay analyzer designed for clinical and research laboratories; runs 120-180 tests per hour, FDA Class 1 Exempt, single-technician operation with built-in refrigeration and continuous reagent/sample loading.
• Oxidized LDL ELISA (K 7810.US) Enzyme-linked immunosorbent assay for the quantitative measurement of oxidized low-density lipoprotein in serum or plasma samples; FDA Class 1 Exempt.
• 1,25 (OH)2 Vitamin D ELISA Immunoassay for the quantitative detection of 1,25-dihydroxyvitamin D in serum, plasma, or cell culture media using competitive EIA with monoclonal antibody.
• IDK EDN ELISA Enzyme immunoassay for the quantitative measurement of eosinophil-derived neurotoxin (EDN) in serum, plasma, stool, urine, and other biological samples.
• Histamine Elimination Ratio (HERO) ELISA Diagnostic assay for assessing histamine degradation capacity by measuring the ratio of diamine oxidase to histamine, used for evaluating histamine intolerance.
• Gluten Fecal ELISA (Quantitative) Quantitative enzyme immunoassay for the detection of gluten in human stool samples, used for monitoring compliance with a gluten-free diet in celiac disease patients.
• CLIA Test Kits (ECL100 Compatible) Chemiluminescence immunoassay test kits compatible with the ECL100 analyzer, covering multiple diagnostic categories including anemia, cardiovascular, and gastrointestinal markers; over 50 kits available via Epitope Diagnostics partnership.
• IDKmonitor Therapeutic Drug Monitoring Assays Therapeutic drug monitoring assays for biologics measuring both drug levels and anti-drug antibodies (ADA), including Adalimumab Total ADA ELISA ($915), Golimumab Free ADA ELISA ($1,050), Infliximab, and Etanercept products.
• Hepcidin-25 LC-MS/MS Assay Kit Solid phase extraction (SPE) in 96-well format combined with tandem mass spectrometry for hepcidin-25 measurement using stable isotope-labeled internal standard; priced at $1,159 per kit.
• IDK Extract Stool Collection Tubes Proprietary stool collection tubes designed for optimal sample preparation for gastrointestinal biomarker testing including gluten and EDN assays; 100-count pack at $195 and 2000-count bulk pack available.
• EasySampler Complete Stool Collection Kit Complete stool collection kit for patient sample collection; priced at $11 per kit.
• ImmuTube Immunoaffinity Enrichment Products Proprietary immunoaffinity extraction products used in LC-MS/MS vitamin D testing, enabling precise 1,25-dihydroxy vitamin D3/D2 measurement.
• StatMatic I Microplate Washer and Bottle Top Dispenser Laboratory instrument for ELISA plate washing and reagent dispensing; priced at $489.
• Validation Assistance Services Fee-for-service technical support including assay validation assistance, on-site training, and ongoing remote support for laboratory validation projects; led by Technical Applications Scientists using EP Evaluator software for validation testing.
• Custom Bulk Packaging Service Customized bulk packaging services for high-volume laboratories, including lot sequestration and inventory management, offering volume discounts and cost savings; 20-plate bulk packs available for numerous assays.
• IDK Proficiency Testing Services Proficiency testing services for esoteric tests, providing interlaboratory data comparison with closing dates in March and October annually.

Quantifiable outcome

• 120-180 tests per hour throughput with ECL100 analyzer, operated by single technician
• +3 more outcomes

Named customers4 records

Segments3 records

Ideal customer profiles4 records

Technology focussed Yes

API detail

Has API

No

API docs

API detail

Core technology

AI maturity

App detail

Feature7 records

Partnerships

Four partnerships are on record, tiered core and minor.

• Epitope Diagnostics, Inc.coreTechnology or Integration · 22 October 2025Strategic partnership to offer the ECL100 chemiluminescent analyzer and over 50 CLIA kits across North America. Collaboration aims to improve laboratory efficiency, address staffing challenges, and enhance clinical outcomes by providing high-quality diagnostic solutions. The ECL100 analyzer is compatible with Immundiagnostik's existing product portfolio.
• Immundiagnostik AGcoreTechnology or IntegrationParent company and global manufacturing partner headquartered in Bensheim, Germany, established since 1986. Immundiagnostik AG develops innovative analytical tools trusted by laboratories in more than 70 countries. The North American subsidiary was established to expand access to IDK products in North America.
• Armbruster BiotechnologyminorChannel Partner/ Reseller/ DistributorPartner company affiliated with founder Franz Paul Armbruster, involved in biotechnology distribution and sales support.
• ClinLabminorOthersPartner in the IDK Network for clinical laboratory publications and information resources supporting the diagnostic community.

Scale indicators6 records

Recent moves4 records

Expansion highlights6 records

Direct peers

• Epitope Diagnostics: Direct strategic partner of Immundiagnostik and a competing manufacturer of ELISA and CLIA kits for clinical and research laboratories. Highly comparable product line, customer base, and immunoassay technology stack.
• ALPCO Diagnostics: US-based specialty immunoassay company offering ELISA and chemiluminescence kits across metabolic, GI, and inflammation biomarkers. Closely comparable in product mix, niche focus, and distribution through US clinical and research labs.
• Eagle Biosciences: Specialty immunoassay distributor and manufacturer serving clinical and research labs in North America. Comparable in niche ELISA/CLIA product positioning and in offering assay validation support services.
• Calbiotech: Manufacturer of ELISA kits and immunoassay reagents for clinical and research laboratories, with similar focus on specialty biomarkers and small-team specialty diagnostics distribution.
• Diagnostic Automation / Cortez Diagnostics: Specialty ELISA and immunoassay kit manufacturer serving clinical and research laboratories. Comparable niche product portfolio, pricing model, and target customer base in North American labs.
• MyBioSource: Distributor of ELISA kits, immunoassays, and life-science reagents. Competes with Immundiagnostik for research-lab immunoassay purchasing in North America via a similar online catalog model.

Broad incumbents

• Bio-Techne (R&D Systems): Large life-sciences tools and diagnostics company offering ELISA kits, antibodies, and analyte detection reagents. Overlaps with Immundiagnostik on research-use immunoassays but operates as a much broader incumbent with deeper catalogs.
• DiaSorin: Global specialty diagnostics company with a leading automated chemiluminescence (LIAISON) platform. Directly comparable to the ECL100 in detection technology and to Immundiagnostik's vitamin D and specialty biomarker assays.
• Thermo Fisher Scientific (Diagnostics & Life Sciences): Diversified incumbent offering immunoassays, clinical chemistry analyzers, and analytical instruments. Competes with Immundiagnostik in ELISA/CLIA reagents, sample-prep consumables, and the broader IVD market.

Emerging players

• Abbexa: UK-based manufacturer of ELISA kits, antibodies, and assay reagents with growing North American reach. Comparable in catalog breadth across research biomarkers and in serving niche esoteric assays.

Market position

Strengths5 records

Weaknesses5 records

Competitive moat4 records

Key risks6 records

Key highlights6 records

Customer concentration

• Xx.com/_idkna
• YouTubeyoutube.com/channel/UChyvcVj3oxqg4ABbM2G2TPg
• LinkedInlinkedin.com/company/immundiagnostik-inc
• Instagraminstagram.com/_idkna
• Facebookfacebook.com/idknorthamerica

Compliance2 records

Revenue estimate

Valuation estimate

Number of profiles

Profiles8 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 Immundiagnostik