Diallebo

What Diallebo does

Diallebo (迪亚莱博, legal entity DiYaLab ZJG Biotech Co., Ltd.) is a privately held Chinese in vitro diagnostics (IVD) manufacturer founded in October 2016 in Zhangjiagang, Jiangsu, with a parallel R&D center in Shanghai's Minhang District. The company develops and commercializes laboratory testing products — reagents, automated immunoassay analyzers, and industrial raw materials — focused on autoimmune diseases (systemic lupus erythematosus, rheumatoid arthritis, antiphospholipid syndrome, vasculitis, inflammatory myopathy), neurological diseases (autoimmune encephalitis, demyelinating disease, myasthenia gravis), and adjacent areas including cardiovascular, inflammation, and kidney injury diagnostics. Its core technology platforms span core raw material development (antigen expression and purification, including patented macromolecular transmembrane protein expression) and immune labeling (latex-enhanced immunoturbidimetry, magnetic particle chemiluminescence, time-resolved immunofluorescence, and ultra-sensitive single-molecule immunolabeling under development), with patented 'click chemistry' application for anti-phospholipid antibody detection.

The company operates four commercial product surfaces: (1) chemiluminescence reagents paired with proprietary DL-i9000 (900-3,600 tests/hour), Shine i2900, and Shine i1900 analyzers; (2) immunofluorescence reagents paired with TFL-2000, FIC-M6, and DL-300 analyzers; (3) the DIALAB-branded biochemistry/immunoturbidimetry catalog of 60+ reagents; and (4) industrial raw materials (autoimmune antigens/antibodies, recombinant proteins, neurological research materials) sold to other IVD manufacturers. Revenue derives from one-time reagent kit sales, hardware/instrument sales, and distribution margins on Thermo Fisher's INDIKO PLUS biochemical analyzer, which Diallebo exclusively distributes in China since December 2019. The go-to-market combines direct sales to medical institutions (500+ hospital customers), a regional distributor/agent network, and academic-conference-driven demand generation (CACLP, NCLM, MEDICA, World Health Expo Labs Dubai). Regulatory and quality infrastructure includes ISO 13485 (July 2020), 122 domestic registration certificates, 84 CE certificates, and 50+ patents (including 25+ invention patents and 1 international patent) as of 2024.

Name

Diallebo

Legal name

迪亚莱博（张家港）生物科技有限公司

Website

https://diyalabzjg.com

Company type

Private

Founded year

2016

Operating status

Operating

Short description

Diallebo is a Chinese IVD manufacturer (founded 2016, Zhangjiagang) that develops autoimmune and neurological disease diagnostic reagents, automated immunoassay analyzers, and core raw materials, selling to hospitals, distributors, and IVD manufacturers in China and internationally.

Ownership category

akta.pro rank

Product category

In Vitro Diagnostics

NAICS

In-Vitro Diagnostic Substance Manufacturing (325413), Electromedical and Electrotherapeutic Apparatus Manufacturing (334510)

SIC

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

akta.pro primary industry

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

akta.pro secondary industries

Immunoassay Diagnostics (ELISA, chemiluminescence, serology) (HLAAALAB), Clinical Chemistry & Immunoassay Systems (HLAHAAAA), Reagents, Chemicals & Assay Kits (Buffers, Antibodies, ELISA, Enzymes) (HLAGAIAI)

Keywords

• Autoimmune disease diagnostics
• Neurological disease diagnostics
• In vitro diagnostics reagents
• Chemiluminescence immunoassay
• Immunoturbidimetric reagents

Headquarters

HQ city

Zhangjiagang

HQ country

China

HQ region

Asia

Offices2 records

Markets served

GTM type

B2B

Offering type

Hardware or Manufacturing

Cost components

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

Revenue model

1. IVD Reagents and Test Kits: Clinical diagnostic reagents for autoimmune diseases, neurological diseases, cardiovascular diseases, inflammation, kidney injury. Products include chemiluminescence reagents, immunofluorescence reagents, immunoturbidimetry biochemical reagents. Revenue from sale of registered diagnostic test kits to hospitals and laboratories.
2. Diagnostic Instruments: Sale of automated chemiluminescence immunoassay analyzers (DL-i9000, Shine i2900, Shine i1900) and fluorescence immunoassay analyzers (DL-300, FIC-M6, TFL-2000) to clinical laboratories.
3. Industrial Raw Materials: Sale of self-developed raw materials including autoimmune disease-related antigens, autoimmune disease-related antibodies, other recombinant proteins, and neurological disease-related research raw materials to IVD manufacturers.
4. Exclusive Distribution: Exclusive distributor of Thermo Fisher's fully automated biochemical analyzer INDIKO PLUS in China since 2019, generating revenue through distribution margins.

Pricing tiers

Go-to-market motion3 records

Distribution channels3 records

Marketing channels4 records

Core offering

Diallebo manufactures and sells in vitro diagnostic (IVD) reagents, automated chemiluminescence and fluorescent immunoassay analyzers, and industrial raw materials (antigens, antibodies, recombinant proteins) for the detection of autoimmune diseases, neurological diseases, cardiovascular diseases, inflammation, and kidney injury. Its products are used by hospital laboratories, clinical diagnostic departments, and IVD manufacturers in China and internationally, with a portfolio spanning chemiluminescence, immunofluorescence, and immunoturbidimetry platforms.

Product overview

Diallebo (迪亚莱博) is a biotechnology company specializing in laboratory testing solutions for autoimmune and neurological diseases. The company offers an integrated product portfolio comprising four detection platforms: (1) Chemiluminescence platform with three automated analyzers (DL-i9000, Shine i2900, Shine i1900) and corresponding reagents for autoimmune and cardiovascular disease detection; (2) Immunofluorescence platform with three analyzers (TFL-2000, FIC-M6, DL-300) for autoimmune and infectious disease testing; (3) Biochemistry/immunoturbidimetry platform providing over 60 DIALAB brand reagents including rheumatoid arthritis, kidney function, cardiac, liver function, inflammation, anemia, and lipid panels; (4) Industrial raw materials including autoimmune disease antigens, antibodies, recombinant proteins, and neurological disease research materials. The company operates with core technology platforms for antigen expression/purification and immune labeling, with patented 'click chemistry' technology and 'layers of progressive' coupling processes.

Differentiator

Problem solved

Functional benefit

Brands

• DIALAB: A sub-brand under Diallebo for biochemical reagent products, with over 60 biochemical reagent combinations listed in the product catalog.

Products and services

• DL-i9000 Automated Chemiluminescence Immunoassay Analyzer High-throughput automated chemiluminescence immunoassay analyzer with 900 tests/hour throughput expandable to 3600 tests/hour via 4-unit modular connection; dual backup of key modules, up to 6 hours unattended operation, and supports AE/AP/HRP/ABEI detection systems. For hospital and clinical laboratories.
• Shine i2900 Chemiluminescence Analyzer Compact chemiluminescence immunoassay analyzer with 200 tests/hour throughput, first result within 15 minutes, precision ≤3%, integrated 0.51m³ design, open platform compatible with multiple detection systems. For clinical laboratories.
• Shine i1900 Chemiluminescence Analyzer Desktop chemiluminescence analyzer with 120 tests/hour throughput, first result within 15 minutes, precision ≤3%, compact 0.2m³ design, open platform supporting AE/AP/HRP/ABEI detection systems. For clinical laboratories.
• TFL-2000 Fluorescent Immunoassay Analyzer Fully automatic time-resolved fluorescent immunoassay analyzer with 150 tests/hour throughput, automatic sampling/incubation/testing/card discarding, 50 sample tube capacity and 100 test card capacity. Supports LIS bidirectional communication.
• FIC-M6 Fluorescent Immunoassay Analyzer Six-channel fluorescent immunoassay analyzer with real-time detection, automatic timing/testing/card discarding, LCD touchscreen operation without external PC required. Supports LIS data transmission.
• DL-300 Fluorescent Immunoassay Analyzer Single-channel fluorescent immunoassay analyzer for quantitative detection with 15-minute results, touchscreen operation, stores up to 5000 sample results and 5 calibration curves per assay. Supports LIS data transmission.
• Chemiluminescence Autoimmune Disease Detection Reagents Magnetic particle chemiluminescence reagents for autoimmune disease detection including anti-phospholipid syndrome, vasculitis, rheumatoid arthritis, antinuclear antibodies, inflammatory myopathy, interstitial lung diseases, autoimmune liver disease, autoimmune diabetes, membranous nephropathy, and thyroid-related autoimmune diseases.
• Immunofluorescence Autoimmune Disease Detection Reagents Time-resolved immunofluorescence reagents for autoimmune disease detection covering antiphospholipid syndrome, vasculitis, rheumatoid arthritis, antinuclear antibodies, inflammatory myopathy, and interstitial lung diseases.
• Cardiovascular Disease Detection Reagents (Immunofluorescence) Cardiac biomarker detection reagents including cTnI, cTnT, H-FABP, myocardial triad (cTnI+Myo+CK-MB), NT-proBNP, D-Dimer, and HCY for diagnosis of acute coronary syndrome, heart failure, and thromboembolic diseases.
• Inflammation Detection Reagents Inflammatory biomarker detection reagents including IL-6, PCT, hs CRP, and SAA+CRP combination for differentiating infectious from non-infectious inflammation.
• Kidney Injury Detection Reagents Renal injury biomarkers including NGAL and MALB for acute and chronic kidney injury diagnosis.
• Biochemistry Reagent Catalog (DIALAB Brand) Over 60 biochemistry reagent products under the DIALAB sub-brand including rheumatoid arthritis assays (RF, ASO, MMP-3, Anti-CCP), interstitial pneumonia (KL-6), renal function, cardiac markers, liver function, inflammation, anemia, and lipid panels.
• Anti-CCP 2nd Generation Latex Enhanced Immunoturbidimetric Reagent Second-generation rheumatoid arthritis diagnostic reagent with extended linearity range of 25-500 U/mL, achieving 95% clinical coincidence rate vs reference systems. Features 'Flexible' long-chain technology and 'Layers of Progressive' coupling process.
• KL-6 (Sialylated Glycoprotein Antigen-6) Detection Reagent Latex-enhanced immunoturbidimetric assay for interstitial lung disease diagnosis; KL-6 is a sensitive, specific, early, and non-invasive biomarker for ILD with correlation with Sekisui β2>0.95.
• 13 Quantitative Urine Assays Comprehensive urine protein detection panel including MALB, β1-MG, β2-MG, UTRF, UIgG, RBP, CREA, UTP, UKappa, ULambda, Uglu, U-NAG, and Uβ2-MG for early kidney lesion diagnosis and treatment evaluation.
• CKMB-MASS Assay Creatine kinase isoenzyme MB mass detection reagent using monoclonal antibodies; resolves CK result inversion issues, unaffected by temperature or storage time; correlation with Roche chemiluminescence ~0.97.
• Nervous System Disease Detection Reagents Comprehensive neurological disease biomarker detection including autoimmune encephalitis (NMDAR, AMPA1, APMA2, VGKC/LGI1, CASPR2, GABA B receptor), central demyelinating diseases (AQP4, MOG, MBP, NfL), myasthenia gravis (AChR, MuSK, LRP4), and Alzheimer's/Parkinson's biomarkers (NfL, GFAP, UCH-L1, Tau, Aβ40, Aβ42).
• Autoimmune Disease-Related Antigens (Industrial Raw Material) Self-developed antigens for autoimmune disease testing including CCP, RF, β2 glycoprotein I, dsDNA, SSA, SSB, protease 3, MPO, Jo-1, Sm, nucleosome, AMA-M2, sp100, gp210; supplied to IVD reagent manufacturers.
• Autoimmune Disease-Related Antibodies (Industrial Raw Material) Self-developed antibodies for autoimmune disease testing including anti-CCP, RF, β2 glycoprotein I, anti-cardiolipin, anti-dsDNA, anti-SSB, anti-Jo-1, anti-SmD, ANA, AMA-M2, anti-gp210, anti-Scl-70, anti-PR3, anti-TPO, anti-GAD65, anti-IAA, and anti-KL6; supplied to IVD reagent manufacturers.
• Other Recombinant Proteins (Industrial Raw Material) Recombinant proteins including enzymes (IdeS, SENP2, TEV, EK, CPB, trypsin, aprotinin, KLK1, KLK7, Benzonase, BsaI, PNGaseF, EndoS), growth factors (hEGF, hIGF-1, hbFGF), and alkali-resistant ProteinA; supplied to IVD reagent manufacturers.
• Neurological Disease Research Raw Materials Research-grade raw materials for neurological disease testing including AQP4 (aquaporin-4), MOG (myelin oligodendrocyte glycoprotein), MBP (myelin basic protein), NMDAR (N-methyl-D-aspartate receptor), GFAP (glial fibrillary acidic protein), and NFL (neurofilament protein); supplied to IVD reagent manufacturers.
• Biochemistry Bulk Reagents Biochemical intermediate products for diagnostic reagent manufacturing including enzymes, growth factors, and ligands; supplied to IVD reagent manufacturers.
• MDA5 Antibody Rapid Detection Kit Rapid detection kit providing 15-minute MDA5 antibody results for dermatomyositis diagnosis; designed for rapid, on-site precision diagnosis.
• COVID-19 Antibody Detection Kit COVID-19 antibody test kit CE-certified in May 2020 and included in the Chinese Ministry of Commerce export whitelist; sold internationally.

Quantifiable outcome

• Anti-CCP clinical coincidence rate of 95% compared to reference systems
• +3 more outcomes

Named customers1 record

Segments3 records

Ideal customer profiles3 records

Technology focussed Yes

API detail

Has API

No

API docs

API detail

Core technology

AI maturity

App detail

Integration2 records

Feature4 records

Partnerships

Three partnerships are on record, tiered core and minor.

• Peking University People's Hospital (北京大学人民医院)coreStrategic or Co-development Partner · 9 April 2026Strategic R&D partnership established in 2023 with joint R&D center. In 2026, the joint R&D center was awarded Beijing Key Laboratory status. Partnership focuses on industry-university-research collaboration during the Science and Technology Innovation Transformation Month. Company signed heavyweight agreement at the 4th Science and Technology Innovation Transformation Month event.
• Thermo Fisher Scientific (赛默飞世尔)coreChannel Partner/ Reseller/ Distributor · 1 December 2019Exclusive distribution partnership for Thermo Fisher's fully automated biochemical analyzer INDIKO PLUS in China since December 2019. Company serves as sole distributor for this product line in the Chinese market.
• FerMat Biotech (费玛生物科技有限公司)minorOthersRelated entity - Shanghai Fermat Biotech Co., Ltd. established in September 2015. HR recruitment contact: [email protected]

Scale indicators6 records

Recent moves6 records

Expansion highlights6 records

Direct peers

• Snibe (Shenzhen New Industries Biomedical Engineering): Leading Chinese chemiluminescence immunoassay IVD manufacturer with MAGLUMI series analyzers and broad autoimmune/infection disease reagent menus. Direct competitor to Diallebo's chemiluminescence platform in Chinese hospital laboratories.
• Hotgen Biotech: Chinese IVD company with chemiluminescence, immunofluorescence, and rapid test platforms. Comparable business model and target market to Diallebo with overlapping autoimmune and infectious disease menus.
• YHLO Biotech: Chinese IVD company specializing in chemiluminescence immunoassay systems and autoimmune disease diagnostics. Competes directly with Diallebo in the autoimmune chemiluminescence reagent segment in China.
• Autobio Diagnostics: Major Chinese IVD manufacturer with comprehensive chemiluminescence, microbiology, and clinical chemistry platforms including autoimmune disease test menus. Direct competitor across multiple of Diallebo's product categories.

Broad incumbents

• Mindray (Shenzhen Mindray Bio-Medical): China's largest medical device and IVD company with extensive chemiluminescence, hematology, and clinical chemistry portfolios. Competes broadly with Diallebo across hospital IVD purchasing decisions.
• Roche Diagnostics: Global IVD leader whose cobas and Elecsys chemiluminescence platforms are the gold standard benchmark Diallebo compares against (CK-MB mass correlation ~0.97). Dominant share in Chinese tier-1 hospital laboratories.
• Inova Diagnostics (Werfen): Global leader in autoimmune disease diagnostics with comprehensive ELISA, chemiluminescence, and multiplex platforms. Sets the benchmark for autoimmune IVD that Diallebo's products must match in clinical validation.

Emerging players

• AESKU Diagnostics: Germany-based autoimmune diagnostics specialist with broad autoimmune disease testing menu. Comparable specialty focus on autoimmune IVD as Diallebo, with established international distribution.
• Tellurium Life Sciences (TLL): Emerging player focused on autoimmune disease diagnostics, representing the type of niche specialist competitor Diallebo encounters in the specialty autoimmune IVD segment.

Regional players

• KingMed Diagnostics: Largest Chinese independent clinical laboratory network that purchases IVD reagents and instruments at scale. Represents both a potential customer channel and a competitive threat through in-house assay development.

Market position

Strengths5 records

Weaknesses5 records

Competitive moat4 records

Key risks6 records

Key highlights7 records

Customer concentration

Compliance2 records

Revenue estimate

Valuation estimate

Number of profiles

Funding overview

Funding rounds1 record

Investors5 records

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 Diallebo