Calbiotech

What Calbiotech does

Calbiotech Inc. is a privately held in vitro diagnostics (IVD) manufacturer founded in 1999 and headquartered in El Cajon, California. The company operates an FDA-registered, ISO 13485:2016 certified manufacturing facility producing immunoassay products across multiple diagnostic modalities, including ELISA, chemiluminescence immunoassay (CLIA), lateral flow, and molecular assays. Its core technical competency is in immunoassay development and reagent manufacturing, supported by an in-house instrument engineering capability through the Moduline Systems product line of modular ELISA automation equipment (dispensers, washers, conveyors, manifolds, syringe sets).

The company's product portfolio spans approximately 111 ELISA kits covering infectious disease, autoimmune disorders, thyroid markers, fertility markers, neonatal screening, cardiac markers, cancer markers, and animal research, alongside reagents, substrates, antigens, antibodies marketed under the Immunovision sub-brand, and veterinary diagnostics. Pricing for ELISA kits ranges from $300 to $750 and Moduline instruments from $40 to $20,500. Beyond catalog products, Calbiotech provides contract manufacturing services including technology transfer, regulatory pathway support, reagent production, fill-finish and lyophilization, custom conjugations, microplate coating, analytical and clinical validations, and kitting and fulfillment.

Calbiotech operates a dual-revenue model combining catalog product sales through a Shopify-powered e-commerce storefront with direct enterprise sales for contract manufacturing engagements. Its primary growth segment is international IVD companies seeking U.S.-based manufacturing to mitigate import tariffs and access the U.S. market, with one disclosed European partner reporting $500,000+ in annual savings and a three-month technology transfer timeline. Secondary segments include academic, pharmaceutical, and clinical research laboratories purchasing research-use ELISA kits and reagents. Go-to-market combines inside sales (phone/email), direct field engagement for contract manufacturing, e-commerce, and trade-show participation, including ADLM 2026. The company is privately owned with no disclosed funding rounds, institutional investors, or executive team in public sources.

Name

Calbiotech

Legal name

Calbiotech Inc.

Website

https://modulinesystems.com

Company type

Private

Founded year

1999

Operating status

Operating

Headcount range

11–50 employees

Short description

Calbiotech is an FDA-registered, ISO 13485:2016 certified contract manufacturer of immunoassays serving international IVD companies and research institutions. It offers 111+ ELISA kits, reagents, antigens, antibodies, veterinary diagnostics, and the proprietary Moduline line of automated ELISA processing instruments.

Ownership category

akta.pro rank

Product category

In Vitro Diagnostics Manufacturing

NAICS

In-Vitro Diagnostic Substance Manufacturing (325413), Analytical Laboratory Instrument Manufacturing (334516)

SIC

In Vitro & In Vivo Diagnostic Substances (2835), Laboratory Analytical Instruments (3826)

akta.pro primary industry

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

akta.pro secondary industries

Immunoassay Diagnostics (ELISA, chemiluminescence, serology) (HLAAALAB), Biomarker Assay & Reagent Development (LDT/IVD assay design, antibodies/standards/controls) (HLAAAMAL), Diagnostic & Laboratory Packaging (Specimen Containers, Transport Tubes) (IMALAIAF)

Keywords

• Immunoassay manufacturing
• ELISA kits
• IVD contract manufacturing
• Diagnostic reagents
• Moduline automation

Headquarters

HQ city

El Cajon

HQ country

United States

HQ region

North America

Offices1 record

Markets served

GTM type

B2B

Offering type

Hardware or Manufacturing

Cost components

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

Revenue model

1. ELISA and CLIA Product Sales: Sale of manufactured ELISA kits, reagents, antigens, antibodies, and related IVD products through e-commerce platform. Products include research assays, veterinary diagnostics, and Moduline instrument systems.
2. Contract Manufacturing Services: Full-spectrum IVD manufacturing services for international diagnostic companies including contract manufacturing (ELISA, CLIA, lateral flow, molecular formats), reagent production, fill-finish & lyophilization, and regulatory/technical transfer support.
3. Custom Manufacturing Services: Custom services including analytical & clinical validations, assay development, custom conjugations (protein/antibody labeling), formulation & filling, microplate coating, and kitting & fulfillment.

Pricing tiers

Go-to-market motion2 records

Distribution channels2 records

Marketing channels6 records

Core offering

Calbiotech develops, manufactures, and sells immunoassay products including ELISA and CLIA kits, diagnostic reagents and substrates, antigens and antibodies, and veterinary diagnostics, along with the Moduline line of automated ELISA processing instruments. It also provides FDA-registered, ISO 13485:2016 certified contract manufacturing and technology transfer services to international IVD companies seeking U.S.-based production.

Product overview

Calbiotech is an FDA-registered and ISO 13485:2016 certified manufacturer specializing in immunoassay development and manufacturing. The company's product portfolio includes four core product lines: ELISA Kits (research assays for human and animal research covering thyroid markers, fertility markers, diabetes markers, allergy markers, anemia markers, growth markers, bone metabolism markers, inflammatory markers, cancer markers, cardiac markers, drugs of abuse, autoimmune disorders, infectious disease, and neonatal screening), Reagents & Substrates (consumables including blocking buffers, coating buffers, HRP conjugate diluent, TMB substrate, stop solution, wash buffer), Antigens & Antibodies (Immunovision branded products), and Moduline Systems (automated ELISA processing equipment including dispensers, wash pumps, vacuum pumps, manifolds, tubing, syringes, and conveyors). Additionally, Calbiotech offers comprehensive manufacturing services including contract manufacturing (ELISA, CLIA, lateral flow, molecular formats), reagent production, fill-finish & lyophilization, regulatory & technical transfer support, microplate coating, kitting & fulfillment, custom conjugations, analytical & clinical validations, and formulation & filling. The company serves as a U.S. manufacturing base for international IVD and pharmaceutical companies seeking FDA and ISO quality compliance.

Differentiator

Problem solved

Functional benefit

Brands

• Moduline Systems: A product line of automated dispensing and washing systems including dispensers, conveyors, wash pumps, vacuum pumps, and manifold assemblies for microplate processing.
• Immunovision

Products and services

• ELISA Kits Comprehensive range of ELISA and CLIA assays for human and animal research, covering hormone, autoimmune disorders, cancer, infectious diseases, fertility, neonatal screening, cardiac markers, and other diagnostic markers.
• Reagents and Substrates

Quantifiable outcome

• $500,000+ annual savings from tariffs alone for one European IVD partner
• +1 more outcomes

Named customers1 record

Segments3 records

Ideal customer profiles3 records

Technology focussed No

API detail

Has API

No

API docs

API detail

Core technology

AI maturity

App detail

Feature3 records

Scale indicators5 records

Recent moves5 records

Expansion highlights5 records

Direct peers

• Abcam: Abcam (acquired by Danaher) is a direct peer producing antibodies and ELISA kits for research applications; it competes directly with Calbiotech's Immunovision antigens/antibodies line and research ELISA catalog.
• Creative Diagnostics: Creative Diagnostics is a direct peer offering ELISA kits, immunoassay reagents, antigens, and antibodies, plus IVD contract manufacturing services — closely mirroring Calbiotech's catalog breadth and CDMO positioning in the specialty immunoassay niche.
• Bio-Techne: Bio-Techne (parent of R&D Systems) is a direct peer — it manufactures ELISA kits, immunoassay reagents, antibodies, and proteins for research and diagnostic applications, serving the same academic, pharmaceutical, and clinical research customers as Calbiotech with overlapping assay menus.
• EKF Diagnostics: EKF Diagnostics is a direct peer manufacturing immunoassay reagents and IVD products for clinical and research markets; its contract manufacturing arm competes with Calbiotech for European and international IVD partner engagements.
• Meridian Bioscience: Meridian Bioscience is a direct peer focused on diagnostic immunoassays, reagents, and IVD contract manufacturing; it competes with Calbiotech's CDMO business for international IVD companies seeking US-based manufacturing capacity.
• Eagle Biosciences: Eagle Biosciences is a direct peer distributing and manufacturing ELISA kits and immunoassays across similar biomarker panels (cardiac, fertility, infectious disease, etc.), serving academic and clinical research labs in the same product category as Calbiotech.

Emerging players

• Arbor Assays: Arbor Assays is an emerging player producing specialty ELISA kits for research applications across hormone, inflammation, and disease biomarkers, with a narrower catalog than Calbiotech but overlapping customer base in academic and preclinical research.
• Elabscience: Elabscience is an emerging player — a China-based manufacturer with broad ELISA and immunoassay reagent offerings sold globally online — competing directly with Calbiotech on price-sensitive research-use catalog products.

Broad incumbents

• Bio-Rad Laboratories: Bio-Rad is a broad incumbent manufacturing ELISA kits, immunoassay reagents, and laboratory automation equipment, with established presence across the same biomarker categories and research customer base that Calbiotech serves.
• Thermo Fisher Scientific: Thermo Fisher is a broad incumbent that manufactures ELISA reagents, immunoassays, and laboratory automation instruments (including microplate processors competing with Moduline), serving the same research and IVD customers but at vastly greater scale and breadth.

Market position

Strengths5 records

Weaknesses5 records

Competitive moat4 records

Key risks6 records

Key highlights7 records

Customer concentration

• Xx.com/calbiotech
• YouTubeyoutube.com/results?search_query=calbiotech
• LinkedInlinkedin.com/company/calbiotech-inc_4
• Instagraminstagram.com/calbiotech_inc

Compliance3 records

Revenue estimate

Valuation estimate

Number of profiles

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 Calbiotech