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.
What We Stand For
Supply only TGA-registered IVD devices that meet Australian regulatory requirements for in vitro diagnostic use.
Provide full technical documentation including IFUs, Safety Data Sheets, and ARTG references for every product.
Partner with manufacturers who hold ISO 13485 quality management certification for medical device production.
Support laboratories with responsive service, competitive pricing, and consistent stock availability.
Connecting Australian Laboratories 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 — an AI-powered system using real-time privacy-preserving de-identification to detect falls, incidents, and critical safety events in healthcare facilities.
"We supply products across three areas — diagnostic testing, forensic science, and patient safety — each requiring the same commitment: regulatory rigour, complete documentation, and reliable supply for Australian professionals."
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.
Patient Safety Monitoring
AI-powered patient movement monitoring using DeCloak technology. Real-time detection of falls and critical safety events in healthcare facilities — with built-in privacy-preserving de-identification.
Australian Laboratories & Healthcare Facilities
We supply across the Australian healthcare and scientific sector.
Regulatory Confidence in Every Product
Five reasons Australian laboratories choose Advanced Biotech as their trusted diagnostic supply partner.
As 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.
Every 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.
Direct 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.
We 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.
Our 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. 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.
IVD
CLSI
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.
BioMaxima MIC Strips
Gradient diffusion MIC test strips for quantitative antimicrobial susceptibility testing. Covers bacterial, resistance, fungal, and targeted panels — validated to EUCAST and CLSI methodology.
View product Reproductive HealthFertility & Reproductive Health
High-sensitivity ovulation, pregnancy, and IVF support diagnostics for fertility clinics and IVF units. Designed for the precise monitoring requirements of assisted reproduction.
View product Forensic ScienceForensic Products
RSID immunochromatographic assays for human blood, saliva, semen, and multi-fluid identification. Trusted by forensic laboratories and crime scene investigators globally.
View product Patient Safety · Not a Medical DevicePatient Movement Monitoring — DeCloak
AI-powered real-time patient movement tracking and critical event detection. Privacy-preserving de-identification built in. For patient safety purposes only — not TGA registered.
View productContact Advanced Biotech
Contact us for product information, pricing, ordering, or technical enquiries. We supply to accredited diagnostic laboratories across Australia.