Seramun Diagnostica

What Seramun Diagnostica does

Seramun Diagnostica GmbH is a German in vitro diagnostics (IVD) manufacturer headquartered in Heidesee, Brandenburg, founded in November 1992 by Prof. Dr. med. T. Porstmann. The company develops, produces, and markets enzyme immunoassay-based products and research reagents for medical and veterinary diagnostics, with all key substances — substrates, stabilizers, antibodies, and antigens — developed and manufactured in-house at its German facility. Its core product platforms include Serazym® ELISA kits (infectious disease, gastrointestinal, gastroenterology/pancreatic elastase, and vaccine QC), Seraline® line immunoassays (LIA) on nitrocellulose membranes for infectious and autoimmune disease detection, SeraSpot® microarray-based multiparameter spot immunoassays in 96-well plates read by the proprietary Seramun SpotSight® automated imaging system, and a broad reagent portfolio of substrates (TMB-based SeraBlue®, AP-based SeramunGelb, chemiluminescent SeramunLux®, membrane and chip substrates), stabilizers, buffers, block solutions, conjugates, affinity-purified and labelled antibodies, and bacterial and viral recombinant antigens.

The company's revenue model is hybrid. Its primary commercial offering is the sale of catalog IVD kits and reagent components (one-time license/product sale) to medical diagnostic laboratories, vaccine manufacturers, and other IVD companies. A secondary revenue stream consists of professional services — custom polyclonal and monoclonal antibody production/purification/conjugation, recombinant protein expression (E. coli and Baculovirus/insect cell), peptide synthesis (via partnership with Charité Berlin), full assay development with CE documentation, and custom reagent filling — sold primarily to other IVD manufacturers requiring integrated custom development. Products reach end-users through a global distributor network: BIOZOL Diagnostica is the exclusive German distributor for SeraSpot, Gold Standard Diagnostics Europe is the exclusive worldwide distributor for Serazym gastrointestinal ELISA kits, and R-Biopharm distributes pancreatic elastase ELISA worldwide while R-Biopharm China and R-Biopharm France handle their respective national markets. Additional regional distributors cover Bulgaria, Czech Republic, Ecuador, Hungary, Norway, Poland, Slovakia, Switzerland, UAE, UK, USA, and Yemen. The company holds ISO 13485:2016 certification (since 1998), CE marking under IVDD Directive 98/79/EC, and has achieved EU IVDR Regulation (EU) 2017/746 certification for H. pylori and Vasculitis products. Primary customer segments are medical diagnostics laboratories (infectious disease, autoimmune, GI, gastroenterology testing), vaccine manufacturers (host-cell protein impurity QC), veterinary diagnostics, and IVD companies requiring custom development services.

Name

Seramun Diagnostica

Legal name

Seramun Diagnostica GmbH

Website

https://seramun.com

Company type

Private

Founded year

1992

Operating status

Operating

Headcount range

101–250 employees

Short description

Seramun Diagnostica GmbH is a German in vitro diagnostics manufacturer producing enzyme immunoassay kits (ELISA, line, and microarray), substrates, antibodies, and antigens for medical, veterinary, and vaccine QC applications, distributed globally through regional distributors.

Ownership category

akta.pro rank

Product category

In-vitro Diagnostics (IVD) Reagents and Kits

NAICS

In-Vitro Diagnostic Substance Manufacturing (325413), Pharmaceutical and Medicine Manufacturing (3254)

SIC

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

akta.pro primary industry

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

akta.pro secondary industries

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

Keywords

• In-vitro diagnostics reagents
• Immunoassay kits
• ELISA kits manufacturing
• Microarray diagnostic kits
• Antibody production services

Headquarters

HQ city

Brandenburg

HQ country

Germany

HQ region

Europe

Offices1 record

Markets served

GTM type

B2B

Offering type

Hardware or Manufacturing

Cost components

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

Revenue model

1. In-vitro Diagnostic Products: Sale of laboratory diagnostics products including substrates (ELISA, membrane, chip, chemiluminescent), stabilizers, ELISA kits, LIA kits, Spot kits, antibodies, antigens, and conjugates for medical and veterinary diagnostics applications.
2. Antibody Services: Production, purification, and conjugation services for polyclonal and monoclonal antibodies. Includes basic and extended service packages with monthly bleedings for polyclonal antibodies, and hybridoma screening/selection for monoclonal antibodies.
3. Antigen Services: Recombinant protein production using E.coli-based expression and Baculovirus-mediated expression in insect cells. Customized approaches using customer vectors or commercial/in-house vector backbones.
4. Assay Development Services: Comprehensive service including antigen expression/purification or peptide synthesis for antibody production, assay development and evaluation including technical documentation for CE certification.
5. Custom Filling Solutions: Fully automated filling solutions for reagents in vials (Zinsser Polyvials, Nalgene Vials) with individual labeling solutions.
6. Peptide Synthesis Services: Peptide production up to 50 amino acids in partnership with Charité hospital Berlin. Optional HPLC purification and mass spectrometry quality control.

Go-to-market motion3 records

Distribution channels4 records

Marketing channels3 records

Core offering

Seramun Diagnostica develops, manufactures, and distributes in-vitro diagnostic immunoassay reagents and kits — including substrates, stabilizers, antibodies, antigens, Serazym ELISA kits, Seraline line immunoassays, and SeraSpot microarray assays — for medical and veterinary diagnostics, vaccine quality control, and contract services (custom antibody production, purification, conjugation, recombinant protein expression, peptide synthesis, assay development, and custom filling). Products are sold globally through an exclusive and non-exclusive distributor network across Europe, the Middle East, Asia, North America, and South America, complemented by direct contract development services for IVD manufacturers.

Product overview

Seramun Diagnostica GmbH is a German in vitro diagnostics manufacturer offering a comprehensive portfolio of laboratory diagnostics and research reagents for medical and veterinary diagnostics. The product portfolio centers on enzyme immunoassays with ready-to-use, color-coded reagents. Core product lines include: Serazym® ELISA kits (including infectious disease, gastrointestinal, gastroenterology/pancreatic elastase, and vaccine control/QC-ELISA variants) for microplate-based detection; Seraline® line immunoassays (LIA) for strip-based detection of infectious and autoimmune diseases; SeraSpot® microarray spot immunoassays for multiplexed detection in 96-well format with automated reading via SpotSight® devices and software; and substrates (TMB-based, chemiluminescent, membrane, and chip substrates) along with stabilizers (for HRP/AP conjugates, proteins, and solid phase) and other reagents (buffers, block solutions, conjugates, antibodies, and antigens) as essential components for assay construction. The company provides contract services including custom antibody production (polyclonal/monoclonal), purification, conjugation, recombinant protein expression, peptide synthesis, assay development, and custom filling solutions. The products are distributed globally through a network of regional distributors.

Differentiator

Problem solved

Functional benefit

Brands

• Serazym: Brand name for ELISA kits including tests for infectious diseases, gastrointestinal infections, vaccine control, and gastroenterology (pancreatic elastase).
• Seraline
• SeraSpot
• Seramun SpotSight
• SeramunStab
• SeramunBlau
• SeramunGelb
• SeramunPurple
• SeramunLux
• SeramunBlock
• SeraBlue

Products and services

• Substrates Ready-to-use substrates for ELISAs, membrane and chip assays, including TMB-based colorimetric substrates (SeramunBlau), pNPP-based substrates for alkaline phosphatase (SeramunGelb), BCIP membrane substrates (SeramunPurple), chemiluminescent substrates for HRP (SeramunLux), and SeraBlue REACH-compliant TMB substrates with 36-month shelf life. For IVD manufacturers and diagnostic laboratories.
• Stabilizers Protein and conjugate stabilizers (SeramunStab range including STplus, NPK, STpoly3, STA7, STM3, STAP, STAP2, STpur, STB, STD, NPLC, NPHC) used in immunoassays to maintain activity and extend shelf life of HRP/AP conjugates, proteins, and solid-phase bound components. For IVD reagent manufacturers.
• Buffer Solutions Concentrated stock solutions for washing and incubation buffers used in immunoassays with long shelf life and effective reduction of nonspecific binding. For diagnostic kit manufacturers and research laboratories.
• Block Solutions Postcoating solutions (SeramunBlock) for preservation and stabilization of proteins on different surfaces including nanoparticles, nitrocellulose membranes, and ELISA plates. For IVD manufacturers.
• Conjugates Enzyme-labeled detection systems including Protein A-HRP, Protein A-Biotin, Streptavidin-HRP, and Streptavidin-poly-HRP conjugates used as secondary reagents in immunoassays. For IVD manufacturers and research laboratories.
• Affinity Purified Antibodies Specific antibodies isolated from the IgG fraction of hyperimmune serum by immunoadsorption chromatography, suitable for solid-phase or capture antibody use in immunoassays. For IVD manufacturers and research laboratories.
• Labelled Antibodies Affinity-purified antibodies labelled with HRP, poly-HRP, AP, FITC, or Biotin for use as detection reagents in immunoassays. For IVD manufacturers and research laboratories.
• Bacterial Antigens Recombinant bacterial antigens including Borrelia (for Lyme disease diagnosis) and Clostridium (for C. difficile and C. perfringens detection), available as GST fusion and His-tag proteins. For IVD assay developers.
• Viral Antigens Recombinant viral antigens including Parvovirus B19, Astrovirus, Rotavirus, Epstein-Barr Virus, and SARS-CoV-2 for diagnostic assay development. For IVD manufacturers.
• Serazym Infectious Diseases ELISA Kits ELISA kits using HRP-labelled antibodies with ready-to-use, color-coded reagents for detection of infectious diseases including Francisella tularensis, with uniform sample dilution, incubation times, temperature, and standard curves adaptable to ELISA processors. For clinical and veterinary diagnostic laboratories.
• Serazym Gastrointestinal Infections ELISA Kits ELISA kits for detection of gastrointestinal pathogens including Adenovirus, Entamoeba histolytica, Rotavirus, Verotoxin, Cryptosporidium, C. difficile, Astrovirus, Norovirus, Campylobacter, Giardia, H. pylori, and C. difficile GDH. For clinical diagnostic laboratories.
• Serazym Pancreatic Elastase ELISA ELISA for quantitative determination of pancreatic elastase in feces for diagnosis and follow-up of exocrine pancreatic insufficiency. For clinical diagnostic laboratories, distributed exclusively by R-Biopharm AG.
• Seraline Line Immunoassays (Infectious Diseases) Line immunoassays using recombinant antigens plotted on nitrocellulose membranes for detection of antibodies in patient samples, with results interpreted by band pattern comparison or Seraline scan software. For clinical diagnostic laboratories.
• Seraline Autoimmune LIA Kits Line immunoassays for autoimmune disease detection including Seraline ANA-12 IgG, Vaskulitis-3 IgG, and HepAk-7 IgG. For clinical diagnostic laboratories.
• SeraSpot Spot Immunoassays (Infectious Diseases) Microarray-based multiparameter diagnostics in 96-well microtiter plates using nanoliter-scale printed recombinant proteins, with peroxidase-labelled antibodies and precipitating substrate producing visible blue spots, evaluated by Seramun SpotSight software. For clinical diagnostic laboratories.
• SeraSpot Autoimmune Spot Kits Spot immunoassays for autoimmune disease detection using purified native or recombinant autoantigens printed in microarray format on 96-well plates. For clinical diagnostic laboratories.
• Serazym Control ELISA Kits (Vaccine QC) Host cell protein ELISAs for detection of impurities in vaccine preparations including Serazym Ovalbumin (for egg-cultured influenza vaccines) and Serazym Bovine Serum Albumin (for fetal calf serum-containing media). For vaccine manufacturers.
• Seramun SpotSight Laboratory system for automated evaluation of SeraSpot spot immunoassays, consisting of SpotSight well and SpotSight plate mono devices and SpotSight scan software for high-precision image capture and analysis, processing up to 96 samples within a whole microtiter plate in 7 minutes. For diagnostic laboratories running SeraSpot assays.
• Seraline scan Software Software for automated evaluation and archiving of Seraline line immunoassays using commercially available flatbed scanners, featuring band intensity detection and band/cut-off ratio calculation. For diagnostic laboratories running Seraline assays.
• Antibody Production Service Custom antibody production services for polyclonal antibodies (sheep, rabbit, hens) and monoclonal antibodies (Balb/c mice), with basic and extended service packages including monthly bleedings and hybridoma screening/selection. For IVD manufacturers and research organizations.
• Antibody Purification Service Custom antibody purification by salt precipitation, ion exchange chromatography, or affinity chromatography with FPLC-based purification options for polyclonal and monoclonal antibodies. For IVD manufacturers and research organizations.
• Antibody Conjugation Service Antibody labelling services with HRP, AP, FITC, or Biotin using optimized protocols with activity specifications (HRP RZ ≥ 3; AP activity >5000 U/mg). For IVD manufacturers and research organizations.
• Recombinant Protein Service Custom recombinant protein expression in E.coli and Baculovirus-mediated insect cell systems with milligram-scale production capability using customer vectors or commercial/in-house vector backbones. For IVD manufacturers and research organizations.
• Peptide Synthesis Service Custom peptide synthesis up to 50 amino acids with purity levels (>70%, >80%, >95%) in partnership with Charité hospital Berlin, including optional HPLC purification, mass spectrometry quality control, and KLH conjugation for immunization. For IVD manufacturers and research organizations.
• Assay Development Service Comprehensive assay development services including antigen expression/purification, peptide synthesis for antibody production, assay development, and evaluation including technical documentation for CE certification. For IVD manufacturers.
• Custom Filling Solutions Fully automated filling services for diagnostic reagents in Zinsser Polyvials and Nalgene vials in various sizes, with individual labelling solutions for light-sensitive substances and long-term freezer storage. For IVD reagent manufacturers.

Quantifiable outcome

• Substrate shelf life up to 36 months
• +3 more outcomes

Named customers3 records

Segments4 records

Ideal customer profiles3 records

Technology focussed Yes

API detail

Has API

No

API docs

API detail

Core technology

AI maturity

App detail

Feature6 records

Partnerships

16 partnerships are on record, tiered core, major and standard.

• BIOZOL Diagnostica Vertrieb GmbHcoreChannel Partner/ Reseller/ DistributorExclusive distributor for SeraSpot product range in Germany. Manages sales and distribution of microarray-based SeraSpot diagnostics to German laboratory customers.
• Gold Standard Diagnostics EuropecoreChannel Partner/ Reseller/ DistributorExclusive worldwide distributor for Serazym gastrointestinal infection ELISA kits including Adenovirus, Entamoeba histolytica, Rotavirus, Verotoxin, Cryptosporidium, Clostridium difficile, Astrovirus, Norovirus, Campylobacter, Giardia, H. pylori products.
• R-Biopharm AGmajorChannel Partner/ Reseller/ DistributorR-Biopharm Group companies distribute Seramun products including R-Biopharm China for Chinese market, R-Biopharm France for French market, and R-Biopharm AG for worldwide pancreatic elastase ELISA distribution.
• ELTA 90M Ltd.standardChannel Partner/ Reseller/ DistributorDistributor for Seramun products in Bulgaria.
• MEDISCO Praha, s.r.o.standardChannel Partner/ Reseller/ DistributorDistributor for Seramun products in Czech Republic.
• Laboratorios Quality S.C.C.standardChannel Partner/ Reseller/ DistributorDistributor for Seramun products in Ecuador.
• SYRINX Diagnostic SystemsstandardChannel Partner/ Reseller/ DistributorDistributor for Seramun products in Hungary.
• Montebello Diagnostics ASstandardChannel Partner/ Reseller/ DistributorDistributor for Seramun products in Norway.
• FABIMEX B i W Wiecek sp.j.standardChannel Partner/ Reseller/ DistributorDistributor for Seramun products in Poland.
• JEMO TRADING, spol. s r.o.standardChannel Partner/ Reseller/ DistributorDistributor for Seramun products in Slovakia.
• RUWAG Handels AGstandardChannel Partner/ Reseller/ DistributorDistributor for Seramun products in Switzerland.
• Oxymed Diagnostics FZCstandardChannel Partner/ Reseller/ DistributorDistributor for Seramun products in UAE.
• Apollo ScientificstandardChannel Partner/ Reseller/ DistributorDistributor for Seramun products in United Kingdom.
• Sapphire North AmericastandardChannel Partner/ Reseller/ DistributorDistributor for Seramun products in USA.
• EZO Medical LabstandardChannel Partner/ Reseller/ DistributorDistributor for Seramun products in Yemen.
• Charité Hospital BerlinmajorStrategic or Co-development PartnerPartnership with Department of Biochemistry, Charité hospital Berlin for peptide synthesis services. Peptides up to 50 amino acids are produced in partnership with purity control via mass spectrometry.

Scale indicators3 records

Recent moves2 records

Broad incumbents

• EUROIMMUN (Revvity): Global IVD leader specializing in autoimmune and infectious disease diagnostics including BIOCHIP and line immunoassay technologies. Significantly larger than Seramun but overlaps directly in autoimmune diagnostics (vasculitis, ANA) and LIA-format products.
• Bio-Rad Laboratories: Global life science and diagnostics company with an extensive ELISA kit, immunoassay reagent, and quality controls portfolio. Overlaps with Seramun's Serazym/SeraSpot infectious disease and autoimmune diagnostics and competes broadly in the lab reagent market.
• DiaSorin S.p.A. Italian-headquartered global IVD company focused on immunodiagnostics and molecular diagnostics, with a strong CLIA-based specialty testing menu. Comparable to Seramun in the immunoassay specialty space but with much greater scale, automation, and global reach.

Direct peers

• ALPCO Diagnostics: US-based specialty IVD manufacturer of ELISA kits and immunoassay reagents for research and clinical diagnostics. Comparable size and product scope to Seramun across small-batch specialty immunoassays and OEM/contract development services.
• R-Biopharm AG: German IVD manufacturer focused on clinical and food diagnostics, particularly ELISA and PCR kits. Distributes Seramun's pancreatic elastase ELISA worldwide while competing in adjacent ELISA-based diagnostic niches - making them both partner and direct competitor.
• Mikrogen Diagnostik GmbH: German specialty IVD manufacturer of recombinant antigen-based immunoblots and ELISA kits for infectious and autoimmune diseases. Comparable size, German manufacturing base, and recombinant-antigen-centered product strategy mirror Seramun's LIA and SeraSpot platforms.
• NovaTec Immundiagnostica GmbH: German IVD maker focused on ELISA kits and immunoassay reagents for infectious disease. Similar size, German manufacturing footprint, and antigen/antibody-based product architecture to Seramun's Serazym line.
• BIOZOL Diagnostica Vertrieb GmbH: German distributor and product specialist for life science and diagnostics reagents. Exclusive distributor of Seramun's SeraSpot line in Germany and a comparable channel-led diagnostics reagent specialist in the same region.
• Calbiotech Inc. US-based specialty IVD manufacturer of ELISA kits and immunoassay reagents for infectious disease, autoimmune, and cancer markers. Comparable scale, niche focus, and product architecture to Seramun's Serazym ELISA business.
• Gold Standard Diagnostics Europe: European IVD distributor and product developer offering ELISA and immunoassay kits for infectious disease and autoimmune diagnostics. Exclusive worldwide distributor of Seramun's Serazym GI line and a direct competitor in gastrointestinal ELISA panels.

Market position

Strengths5 records

Weaknesses5 records

Key risks5 records

Key highlights8 records

Customer concentration

• LinkedInlinkedin.com/company/seramun-diagnostica-gmbh

Compliance3 records

Revenue estimate

Valuation estimate

Number of profiles

Profiles2 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 Seramun Diagnostica