✔ CE & EU-IVD Approved India's First Handheld Multi-Parameter POCT

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Point-of-Care Diagnostic Innovation

DX 101
Immunofluorescence
Quantitative Analyzer

India's first portable and handheld multi-parameter POCT device. Compact, user-friendly, and built for rapid quantitative results — in clinics, ICUs, ambulances, and beyond.

🏥 Point-of-Care Ready ⚡ Results in 3–15 min 📱 Android OS 🔋 Long Battery Life ☁️ Always Connected
DX 101 Immunofluorescence Quantitative Analyzer — handheld portable device
50,000+
Test Results Storage
3–15 min
Results Turnaround Time
80+
Test Parameters Available
LIMS / HL7
Seamless Connectivity
Key Features

Engineered for Precision & Portability

A fast, compact analyzer delivering lab-grade quantitative IVD results at the point of care.

🤲

Pocket Portability

Weighs just 400g and running Android OS with an onboard QR/barcode scanner.

⚗️

Quantitative Precision

Get rapid results in 3–15 minutes with excellent correlation to lab reference methods.

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Smart Connectivity

Full support for Wi-Fi, 4G, auto upload & LIMS connectivity (universal HL7 interface), and Bluetooth thermal printing.

Test Menu

Comprehensive Multi-Parameter Testing

Over 80 assay parameters across 12 major clinical categories — all from a single handheld device.

❤️
Cardiac Markers
  • cTnI / hs-cTnI
  • TnT
  • CK-MB
  • BNP / NT-proBNP
  • H-FABP
  • ST2
  • CK-MB / cTnI / Myo
  • CK-MB / cTnI / H-FABP
🩺
Thyroid Function
  • TSH
  • T3 / T4
  • fT3 / fT4
Coagulation
  • D-Dimer
Diabetes
  • HbA1c
🔬
Inflammation
  • SAA
  • IL-6
  • PCT
  • CRP / hs-CRP
  • Calprotectin
Renal Function
  • CysC
  • mAlb / β2-MG / NGAL
🦠
Infectious Diseases
  • Anti-HCV / Anti-TP
  • Anti-HIV / HBsAg
  • Anti-HBs
  • SARS-CoV-2 Ag
  • H. pylori Ag/Ab
  • Influenza A/B
  • Dengue NS1/IgG/IgM
  • RSV/Influenza A/B
🌸
Fertility
  • HCG+β / LH / FSH
  • AMH / PRL
  • Progesterone
  • Estradiol
  • Testosterone
🏷️
Tumor Markers
  • tPSA / fPSA
  • AFP / CEA
  • CA125 / CA19-9 / CA15-3
  • PG I / PG II
☀️
Vitamins
  • 25-OH Vitamin D
  • Folate
  • Vitamin B12
Metabolic
  • Osteocalcin
🧬
Rheumatology
  • RF
  • ASO
  • Anti-CCP
Other Tests
  • Cortisol
  • Total IgE
  • Ferritin
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Sample Types
  • Serum
  • Plasma
  • Whole Blood
  • Capillary Blood
  • Urine
Volume: 10–200 µL depending on assay
🌐
Languages Supported
🇬🇧 English 🇩🇪 German 🇮🇳 Hindi 🇮🇳 Tamil + Customizable
Application Scenarios

Built for Every Care Setting

From bustling emergency departments to remote home visits, DX 101 delivers reliable diagnostics wherever needed.

Hospital ICU application scenario
🏥 Hospital & ICU
Rapid cardiac, coagulation, and inflammation markers for critical care units and emergency departments.
Ambulance point-of-care testing
🚑 Ambulance
Lightweight and battery-powered — enables diagnostic testing during patient transport.
Pharmacy point-of-care testing
💊 Pharmacy & Clinic
Thyroid, diabetes, vitamin, and fertility panels available at pharmacy level for faster patient outcomes.
Remote and home testing
🏡 Remote & Home Testing
Small blood volume, simple operation — ideal for community health workers and home care settings.
🏥Clinic
🚑Emergency
🩺ICU
🚐Ambulance
🩸Blood Bank
👨‍⚕️GP
🏨Ward
💊Pharmacy
❤️CCU
Quality & Compliance

Clinical Credentials & Standards

DX BIOCODE devices are manufactured and certified to meet the most rigorous international clinical and regulatory standards.

📋
Quality Management

ISO 9001:2015

International standard certifying organization-wide quality management, client focus, and continuous operational optimization.

🩺
Medical Device Standard

ISO 13485:2016

Specific global quality management standard verifying safety and manufacturing compliance for diagnostic medical devices.

✈️
Global Export

FSC Certified

Free Sales Certificate validates that the device is legally manufactured and commercially sold without restrictions globally.

🇪🇺
European Conformity

CE Mark

Confirms that the device meets health, safety, and environmental protection standards within the European Economic Area.

🛡️
Regulatory Approved

NMPA Compliant

Evaluates safety and efficacy, certifying the device for clinical diagnostic applications.

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Global Unified Audit

MDSAP Audit

Single regulatory audit satisfying requirements for USA (FDA), Canada (HC), Brazil (ANVISA), Australia (TGA), and Japan (MHLW).

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Diabetes Standard

NGSP Standard

Standardizes HbA1c testing parameters, ensuring direct correlation to the landmark DCCT clinical trials.

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Clinical Chemistry

IFCC Standardized

Standardized calibration metrics aligned with the International Federation of Clinical Chemistry for global lab compatibility.

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In Vitro Diagnostics

IVD Approved

Certified for analyzing clinical samples (blood, plasma, urine) outside the body to deliver accurate quantitative values.

Ready to Transform Your Diagnostic Capability?

Contact DX BIOCODE today to request a demonstration, get a quote, or explore our full product range.