Bioanalytic

What Bioanalytic does

Bioanalytic GmbH is a privately held, family-owned German manufacturer of biomedical and analytical-chemical reagents and in-vitro diagnostics (IVD) founded in 1978 in Umkirch near Freiburg im Breisgau. The company organizes its offering into three core product lines: (1) ThermoClean water-bath stabilization and corrosion protection concentrates for laboratory circulation systems, (2) Biorex and Biogent cleaning concentrates for manual cleaning, analyzer systems, and protein residue removal, and (3) hematology/clinical diagnostics products including the TIC capillary-based erythrocyte/leukocyte/thrombocyte counting kits (Ery-TIC, Leuko-TIC, Thrombo-TIC), McFarland barium-sulfate and polymer turbidity standards, and Neubauer/Thoma counting chambers. Production runs in modern fully and semi-automated facilities with a Class A cleanroom for sterile filling, and the operation is certified to EN ISO 9001 (Quality Management) and EN ISO 13485 (Medical Device QMS), with FDA registration for the U.S. market.

The business model blends direct B2B sales of own-brand specialty reagents with OEM/PLM custom manufacturing for device manufacturers who need reagents filled, labeled, and documented under their own brand. Document-management platforms — SDS-ID International for globally valid Safety Data Sheets and LotDocs International for digital Certificates of Analysis — are layered on top of the physical product, accessible via QR codes on packaging. A fee-based technical consultation service (including telephone consultation at EUR 2.00/minute for OEM customers) monetizes the in-house scientific team. International distribution covers Europe, Asia, Africa, North/Central/South America, and Australia/Oceania, with the company actively recruiting additional regional distributors.

Customers include enterprise OEMs and institutional buyers such as B. Braun Avitum, Bayer, Roche Diagnostics, Siemens, Thermo Fisher Scientific, Carl Roth, Phadia AB, ELITechGroup, Endress+Hauser, and Carl Zeiss Microscopy — over 50 named reference customers. The firm is 100% family-owned across three generations (founder Manfred F. Rüdinger, Managing Director Dr. Ferdinand M. Rüdinger, Deputy Managing Director Philipp C. Rüdinger), has 11-50 employees, and sources 100% renewable electricity (hydropower, wind, solar) since 2020 via a proprietary photovoltaic system. No external investors, no parent company, no public listing, and no disclosed revenue figures are present in the data.

Name

Bioanalytic

Legal name

Bioanalytic GmbH

Website

https://bioanalytic.de

Company type

Private

Founded year

1978

Operating status

Operating

Headcount range

11–50 employees

Short description

Bioanalytic GmbH is a privately held, family-owned German manufacturer founded in 1978 that produces in-vitro diagnostics, calibration standards, buffers, electrolytes, and test kits, serving diagnostic, pharmaceutical, life-science, and industrial OEM customers via direct B2B sales, custom OEM manufacturing, and a global distributor network.

Ownership category

akta.pro rank

Product category

In-vitro Diagnostics Manufacturing

NAICS

In-Vitro Diagnostic Substance Manufacturing (325413), Analytical Laboratory Instrument Manufacturing (334516), Pharmaceutical and Medicine Manufacturing (32541)

SIC

In Vitro & In Vivo Diagnostic Substances (2835), Laboratory Analytical Instruments (3826), Services-Commercial Physical & Biological Research (8731)

akta.pro primary industry

Reagents, Chemicals & Assay Kits (Buffers, Antibodies, ELISA, Enzymes) (HLAGAIAI)

akta.pro secondary industries

Analytical Development & QC Testing (Release/Stability/Potency) (HLAGAGAF), Raw Materials & Critical Reagents Supply (Media/Resins/Cytokines) (HLAGAGAI), Raw Materials & Critical Reagents Supply Services (media, resins, single-use) (HLAAAKAI)

Keywords

• In-vitro diagnostics manufacturing
• OEM reagent manufacturing
• Laboratory cleaning reagents
• Calibration standards and buffers
• Hematology test kits

Headquarters

HQ city

Umkirch

HQ country

Germany

HQ region

Europe

Offices1 record

Markets served

GTM type

B2B

Offering type

Hardware or Manufacturing

Cost components

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

Revenue model

1. Direct Product Sales: Sale of proprietary reagent products under Bioanalytic brand including IVD products, calibration standards, buffer solutions, cleaning reagents, and test kits. One-time purchase model with repeat orders from established customer relationships.
2. OEM Manufacturing Services: Custom manufacturing for OEM customers who require reagents under their own brand labels. Services include product development, formulation, filling, labeling, and packaging. Revenue from both one-time production runs and ongoing supply contracts for device manufacturers.
3. Consulting Services: Technical and scientific consulting services including product consultation, OEM manufacturing consultation, regulatory compliance advice, safety data sheet preparation, and technical device assessment. Fee-based services with telephone consultation at 2.00 EUR/minute for OEM customers.

Pricing tiers

Go-to-market motion3 records

Distribution channels3 records

Marketing channels1 record

Core offering

Bioanalytic GmbH manufactures chemical-analytical reagents and in-vitro diagnostics (IVD), including calibration standards, buffer and electrolyte solutions, cleaning concentrates, and complete hematology test kits. The company sells products under its own brands (ThermoClean, Biorex, Biogent, TIC, McFarland, bioZORB) and provides OEM contract manufacturing of custom-formulated reagents under customer brand labels. Production is carried out in ISO 13485-certified facilities with a Class A cleanroom, and the company serves diagnostic, pharmaceutical, biotech, industrial, and laboratory customers worldwide.

Product overview

Bioanalytic GmbH is a German manufacturer of biomedical and analytical-chemical reagents and in-vitro diagnostics (IVD) founded in 1978. The company operates as a family-owned business and offers a diversified portfolio organized into three main product lines: (1) ThermoClean water bath stabilization and corrosion protection products (DC, 37, 95, BI, CP:BT, CPX, CS, Pool) for laboratory water circulation systems; (2) Biorex and Biogent cleaning product lines for laboratory equipment and analyzers, covering manual cleaning (M/A, M/AH, M/AHD, M/AP, M/AP03, M/NP, M/SC), analyzer concentrates (A, N, S, EC), and general cleaning (BioScreen); and (3) hematology/clinical diagnostics including TIC capillary-based cell counting systems (Ery-TIC, Leuko-TIC, Thrombo-TIC), turbidity standards (McFarland BSS/PMS), counting chambers (Neubauer, Thoma), and associated reagents (EryCount, ThromboCount, LeukoCount). Beyond own-brand products, Bioanalytic provides OEM manufacturing services for device manufacturers requiring custom-labeled reagents in various formats (bottles, vials, ampoules, sachets, reaction tubes) and operates document management services (SDS-ID International, SDS Experts) for safety data sheet delivery. The company holds EN ISO 9001 and EN ISO 13485 certifications covering development, manufacturing, and distribution.

Differentiator

Problem solved

Functional benefit

Brands

• ThermoClean: Water bath stabilizers and corrosion protection products for circulation systems, incubators, and cooling systems. Includes ThermoClean DC, ThermoClean 37, ThermoClean 95, ThermoClean BI, ThermoClean CP:BT, ThermoClean CPX, ThermoClean CS (descaler), and ThermoClean Pool.
• Biorex
• BioScreen
• Biogent
• TIC
• Ery-TIC, Leuko-TIC, Thrombo-TIC
• McFarland
• bioZORB

Products and services

• ThermoClean DC Stabilization concentrate for water circulation systems (water baths, circulating thermostats) with very low foaming action; the de facto standard since 1978 for biological stabilization of water circulation systems.
• ThermoClean 95 Ready-to-use stabilized cooling/tempering liquid on water basis for circulation systems at temperatures from 5 to 98 °C, with metal corrosion protection.
• ThermoClean 37 Ready-to-use stabilized water for biological incubators, prevents contamination of circulating air with active ingredients.
• ThermoClean BI Stabilization concentrate for humidification water in biological incubators (BI), suitable for CO2 incubators.
• ThermoClean CP:BT Metal corrosion protection for water circulation systems (cooling/tempering); biocide-free and compatible with ThermoClean DC and ThermoClean NF.
• ThermoClean CPX Universal protection concentrate for water circulation systems with particularly effective corrosion protection for multimetal compositions (aluminum, copper, brass, bronze, etc.).
• ThermoClean CS Decalcification concentrate based on citric acid with corrosion protection, special quality for device application.
• ThermoClean Pool Anti-algae concentrate for tub and pool, for professional and commercial use.
• Biorex M/A Liquid universal cleaning concentrate for manual cleaning of laboratory equipment (glassware, plastics, stainless steel).
• Biorex M/AH Liquid universal cleaning concentrate for manual cleaning of laboratory glassware with additional color precipitate removal.
• Biorex M/AHD Liquid universal cleaning concentrate for manual cleaning with alkaline, hypochlorite and detergent (foaming).
• Biorex M/AP Liquid cleaning concentrate particularly suitable for manual cleaning of laboratory glassware and for use in ultrasonic baths.
• Biorex M/AP03 Liquid cleaning concentrate for manual cleaning, alkaline, phosphate-free.
• Biorex M/NP Liquid universal cleaning concentrate for manual cleaning of particularly sensitive laboratory equipment, phosphate-free.
• Biorex M/SC Liquid universal cleaning concentrate for manual cleaning of laboratory glassware, particularly effective for limescale deposits.
• BioScreen Cleaning spray for computers, screens, keyboards, printers, devices, controls, phones, work surfaces and other items.
• Biogent-A Alkaline cleaning concentrate for analysis systems, contains cleaning-active detergents and alkalizing agents.
• Biogent-N Neutral rinse and cleaning concentrate for analysis systems, electrolyte- and enzyme-free.
• Biogent-S Acidic cleaning concentrate for analysis systems, contains cleaning-active detergents and acidifying agents.
• Biogent-EC Enzymatically-catalytic protein-splitting cleaning solution for denatured protein deposits from blood, serum, plasma or other protein-containing fluids.
• Silicone Antifoam Emulsion Silicone-based antifoam emulsion for foam reduction in Kjeldahl distillation, cleaning applications, circulating thermostats and other laboratory applications.
• Silicone Solution Solvent Solvent for silicone oils and silicone oil solutions, also for removal of silicone oils.
• Siliconizing Solution Silane solution for siliconizing/hydrophobizing glass, porcelain, and ceramic in laboratory settings such as measuring vessels, pipettes, and centrifuge tubes.
• Silicone Oil Solution For caring impregnation/cleaning of devices, apparatus and instruments made of metal, glass, ceramic and plastics.
• Ethanol ≥99.8%, Denatured Denatured ethanol with 1% MEK, suitable as universal solvent and for laboratory and histology purposes.
• Petroleum, Pure DAB Petroleum benzine (cleaning gasoline), light volatile, pure DAB grade.
• Leuko-TIC 1:20 Blue Single tests with Bioanalytic LeukoCount blue reagent for rapid, simple, clean and precise microscopic leukocyte counting from 20 µl capillary or EDTA blood.
• Ery-TIC 1:200 Dilution 1:200 test kit for rapid, simple, clean and precise microscopic erythrocyte counting from 5 µl capillary or EDTA blood.
• Thrombo-TIC 1:100 Pur Single tests with Bioanalytic Thrombo-Count pur reagent for rapid, simple, clean and precise microscopic thrombocyte counting from 10 µl capillary or EDTA blood.
• EryCount Pur Colorless reagent for microscopic erythrocyte counting, identical to Hayem's reagent.
• McFarland BSS Turbidity Standards Barium sulfate suspension turbidity standards for producing standardized bacterial suspensions, manufactured according to original McFarland procedure.
• McFarland PMS Turbidity Standards Polymer microparticle suspension turbidity standards equivalent to original McFarland BSS, with better shelf life and slower demixing than barium sulfate version.
• Neubauer Improved Counting Chamber Glass counting chamber with two counting grids, including 2 cover slips, used for erythrocyte, leukocyte and thrombocyte counting.
• Thoma Counting Chamber Counting chamber for various applications including leukocyte counting.
• TIC 5 µl Capillary Pack Replacement pack with 100x 5 µl volume capillaries and 100x chamber fill capillaries for use with Ery-TIC products.
• Sodium Hypochlorite Solutions Technically purified chlorine bleaching solutions for use with analysis systems, available in concentrations from 0.5% to 15%.
• Propanol 70% 70% v/v 2-propanol (iso-propanol) for alcoholic cleaning.
• Hydrogen Peroxide 1.5% Hydrogen peroxide solution 1.5% H2O2.
• Hydrogen Peroxide 3.0% Hydrogen peroxide solution 3.0% pharmaceutical quality (Ph. Eur) for aquariums and other applications.
• Ultra Pure Water Sterile ultra-pure water for cell and tissue culture technology applications.
• bioZORB (ChemAdsorb) Adsorber granules for adsorption of spilled chemicals and other liquids.
• Neutralix-S Non-hazardous, non-dangerous substance neutralizer for acids and acid mixtures (sulfuric acid, hydrochloric acid, acetic acid, nitric acid mixtures, etc.).
• Wickerham Card Laminated background comparison card with black and white stripes for visual turbidity assessment.
• McFarland Empty Tubes 10 empty McFarland glass tubes (16.1 x 112.5 mm) with aluminum screw cap, autoclavable.
• Neubauer Improved Disposable Counting Chamber Glass counting chamber with two counting grids for single use, manufactured by Attain.
• Neubauer Improved Plastic bioChip Plastic counting chamber for single use in biotechnology applications.
• OEM Manufacturing Services Custom manufacturing of OEM reagents from individual containers to complete kits with customer branding, including development support, scientific expertise, and technical support for device manufacturers.
• SDS-ID International Service International service for safety data sheets with lifelong valid SDS-ID (safety data sheet identification number) accessible via product labels, QR codes, and product information sheets.
• SDS Experts Service Expert service for safety data sheets (SDS) providing custom SDS with customer data, logos, and all required information in multiple country/language versions according to current laws and regulations.
• Consultation Service Technical and methodological support for products, OEM manufacturing consultation, and foreign product consultation services.

Quantifiable outcome

• 40+ years of customer relationships with leading manufacturers
• +1 more outcomes

Named customers20 records

Segments4 records

Ideal customer profiles5 records

Technology focussed No

API detail

Has API

No

API docs

API detail

Core technology

AI maturity

App detail

Feature6 records

Partnerships

Four partnerships are on record, tiered core and minor.

• SDS-ID InternationalcoreTechnology or IntegrationParticipation in international service providing globally valid SDS-ID (safety data sheet identification number) for product lifecycle management. All safety data sheets are provided via this platform and are accessible via product labels, QR codes, and product information sheets.
• SDS ExpertscoreTechnology or IntegrationExpert service for safety data sheets (SDS) specifically for OEM customers. Creates SDS with customer data, logo, and all required information according to current laws and regulations in multiple language versions.
• LotDocs InternationalcoreTechnology or IntegrationPlatform for providing Certificate of Analysis (CoA) for all products. Certificates are downloadable using batch number (Lot) and expiration date, available anytime.
• Biorapid GmbHminorOthersManufacturer of Neutralix-S neutralization agent for acids and acid mixtures, sold through Bioanalytic product catalog.

Scale indicators5 records

Recent moves5 records

Expansion highlights5 records

Direct peers

• LGC Group: UK-based life-science measurement and testing company providing reference materials, reagents, and standards used in diagnostics and analytical testing. Comparable to Bioanalytic in calibration standards, reference materials (e.g., McFarland turbidity standards), and OEM reagent supply to diagnostics manufacturers.
• Hach Company (Danaher): Specialist in water-analysis reagents, calibration standards, and instruments, part of Danaher's water/environmental platform. Direct overlap with Bioanalytic's water-analysis reagent OEM business, and Hach is already a Bioanalytic customer, confirming shared OEM/reagent relationship structure.
• ELITechGroup: European IVD manufacturer producing clinical chemistry, hematology, and immunodiagnostic reagents and instruments. Closely comparable to Bioanalytic in OEM/private-label reagent manufacturing for hematology and clinical chemistry, and listed as a Bioanalytic customer, confirming direct overlap in OEM offerings.
• Diagnostica Stago: French IVD company focused on hemostasis/coagulation reagents and instruments. Comparable to Bioanalytic in hematology-adjacent IVD reagent manufacturing with global OEM and clinical lab distribution; both serve similar hospital and OEM customer profiles.
• Carl Roth GmbH + Co. KG: German manufacturer and distributor of laboratory chemicals, reagents, and consumables serving research and industrial labs across Europe. Direct comparable to Bioanalytic's branded reagent portfolio, and Bioanalytic already lists Carl Roth as a customer, confirming overlap in the same product category and customer base.
• R-Biopharm AG: German-based developer and manufacturer of diagnostic test kits and reagents for clinical and food/feed analysis. Comparable to Bioanalytic in IVD reagents, OEM/private-label manufacturing, and family-business roots; both target diagnostic OEMs and clinical laboratories with certified reagent solutions.
• Romer Labs: Specialist in diagnostic reagents and test kits for food and feed safety (mycotoxins, allergens, pathogens), part of ERBER Group. Comparable in OEM-style reagent kit manufacturing and reference-material production (e.g., turbidity/calibration standards), targeting regulated laboratory customers globally.

Broad incumbents

• Bio-Rad Laboratories: Global life-science and clinical diagnostics company manufacturing analytical instruments, IVD reagents, and quality controls. Comparable to Bioanalytic in IVD reagent and OEM/PLM supply, but at vastly greater scale with a much broader product portfolio spanning instruments and consumables.
• Phadia AB (Thermo Fisher Scientific): Immunodiagnostics specialist (now part of Thermo Fisher) producing allergy and autoimmunity reagents. Comparable in immunodiagnostic reagent manufacturing for OEMs and clinical labs, and Phadia is listed as a Bioanalytic customer, confirming shared OEM/customer dynamics though Phadia sits at much larger scale.
• Merck KGaA (Life Science / MilliporeSigma): Global life-science tools and reagents giant operating the MilliporeSigma / Sigma-Aldrich brands for buffers, reagents, and analytical consumables. Direct category overlap with Bioanalytic's buffer and reagent lines, but Merck operates at global scale with proprietary brand power Bioanalytic cannot match in commodity reagent segments.

Market position

Strengths5 records

Weaknesses5 records

Competitive moat5 records

Key risks6 records

Key highlights6 records

Customer concentration

• LinkedInlinkedin.com/company/bioanalytic-gmbh

Compliance3 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 Bioanalytic