Advanced Biotech Pty Ltd
Diagnostic & Laboratory Solutions for Australia
We supply TGA-registered in vitro diagnostic medical devices and professional laboratory products to accredited pathology laboratories, hospitals, and research institutions across Australia.
Connecting Australian Laboratories and Healthcare Facilities with Trusted Products
Advanced Biotech Pty Ltd is an Australian distributor of diagnostic medical devices, forensic science products, and patient safety technology. We work directly with accredited international manufacturers to bring validated, regulatory-compliant products to Australian pathology laboratories, hospitals, aged care facilities, and research institutions.
In diagnostic products, we are the Australian Sponsor for the BioMaxima MIC Strip family — TGA-registered gradient diffusion test strips manufactured by BioMaxima S.A. (Poland) and validated to EUCAST and CLSI guidelines (ARTG 524158). We also supply Seratec forensic lateral flow assays for body fluid identification in forensic casework.
In patient safety technology, we are the authorised Australian distributor for DeCloak patient movement monitoring — an AI-powered system using real-time privacy-preserving de-identification to detect falls, incidents, and critical safety events in healthcare facilities without retaining identifiable patient imagery.
What We Supply
We source and distribute diagnostic and laboratory products from manufacturers with established quality systems and regulatory approvals for the Australian market.
Antimicrobial Susceptibility Testing
TGA-registered MIC test strips for quantitative antimicrobial susceptibility testing. The BioMaxima MIC Strip family covers bacterial, resistance, fungal, and targeted panels — validated to EUCAST and CLSI methodology.
Diagnostic Reagents & Media
Microbiological culture media, chromogenic agars, and diagnostic reagents for clinical and reference microbiology laboratories. All products supplied with full technical and safety documentation.
Forensic & Serology Products
Specialist forensic science reagents and rapid serology test kits for professional laboratory use, supplied in accordance with relevant Australian regulatory classifications.
Research Use Products
Research-grade laboratory products for use in non-diagnostic settings. Supplied with clear RUO labelling in accordance with TGA regulatory classification requirements. Not for diagnostic procedures.
Technical Documentation
Current Instructions for Use (IFUs), Safety Data Sheets, ARTG references, and CE documentation for every product. Supporting laboratory quality management systems and NATA accreditation requirements.
Patient Safety Monitoring
AI-powered patient movement monitoring using DeCloak technology. Real-time detection of falls, incidents, and critical safety events in healthcare facilities — with built-in privacy-preserving de-identification. Not a medical device — for patient safety purposes only.
Customer & Technical Support
Direct access to product information, ordering, and technical enquiries. We work closely with laboratory staff to ensure products meet their specific clinical and quality requirements.
Hospital and reference microbiology laboratories
Public health and surveillance programmes
University and research institutions
NATA-accredited pathology services
Pharmaceutical and veterinary laboratories
Regulatory Confidence in Every Product
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Australian Sponsor AccountabilityAs the TGA-registered Australian Sponsor for the BioMaxima MIC Strip family, we hold formal regulatory responsibility for product compliance, post-market vigilance, and adverse event reporting — giving laboratories confidence in their supply chain.
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Complete Documentation PackageEvery product is supplied with current Instructions for Use, Safety Data Sheets, and ARTG references. Documentation is kept current with TGA register changes and manufacturer revisions — supporting NATA accreditation and laboratory quality management systems.
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Responsive Supply and ServiceDirect contact with our team for orders, technical enquiries, and stock availability. We maintain working relationships with our manufacturing partners to support consistent supply for routine laboratory operations.
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Validated Manufacturer PartnershipsWe partner exclusively with manufacturers holding ISO 13485 quality management certification and relevant IVD regulatory approvals (CE-IVD, TGA ARTG). BioMaxima S.A. products are CE-IVD marked and independently validated against EUCAST reference methodology.
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EUCAST & CLSI AlignmentOur AST products are validated and calibrated to current EUCAST broth microdilution reference MIC distributions, ensuring clinical breakpoint application is accurate and audit-ready for Australian laboratory accreditation bodies.
Compliance & Quality Standards
Advanced Biotech Pty Ltd operates as the Australian Sponsor for TGA-registered in vitro diagnostic medical devices. All IVD products distributed by Advanced Biotech Pty Ltd are listed on the Australian Register of Therapeutic Goods (ARTG) and comply with the Therapeutic Goods (Medical Devices) Regulations 2002.
Products supplied by Advanced Biotech Pty Ltd are classified and labelled in accordance with TGA IVD regulatory categories. In vitro diagnostic devices are for professional laboratory use only. Research Use Only (RUO) products are clearly identified and must not be used for diagnostic procedures.
Featured Products
Diagnostic devices, forensic products, and patient safety technology — each sourced from manufacturers with validated quality systems and appropriate regulatory approvals for the Australian market.
Gradient diffusion MIC test strips for quantitative antimicrobial susceptibility testing of bacterial pathogens. Mueller-Hinton Agar. EUCAST/CLSI aligned. Available now.
View productSpecialised panel for resistance mechanism confirmation — ESBL, carbapenemase, and MRSA characterisation. Gradient diffusion on Mueller-Hinton Agar.
View productAntifungal MIC determination for Candida, Aspergillus, and other clinically significant fungi. RPMI 1640 agar. EUCAST antifungal breakpoints.
View productAI-powered real-time patient movement tracking and critical event detection. Privacy-preserving de-identification built in. For patient safety purposes only — not TGA registered, not an IVD.
View productGet in Touch
Contact us for product information, pricing, ordering, or technical enquiries. We supply to accredited diagnostic laboratories across Australia.