Recently, Autobio’s Automated Mass Spectrometry Microbial Identification System, Autof MS Series, has obtained the EU IVDR (In Vitro Diagnostic Regulation) Class C registration certificate from the EU Notified Body.
Since May 26, 2022, the EU has fully implemented the new In Vitro Diagnostic Regulation EU 2017/746 (IVDR). The new regulation imposes stricter requirements on technical documentation review, clinical evaluation, and post-market surveillance, among other aspects. In-vitro diagnostic products of Class B, C, and D all require certification from a Notified Body. These regulatory changes demand manufacturers to ensure higher product quality and traceability throughout the supply chain to the end-users.
Autobio's Autof MS Series is independently developed and manufactured, with multiple proprietary patents in hardware, software, databases, and supporting reagent kits. Compared to traditional identification methods, mass spectrometry detection offers advantages such as simplicity, speed, and accuracy, significantly enhancing laboratory work efficiency. Its main advantages include:
- Long-life laser for stable excitation, leading to faster, more accurate detection, and increased scalability.
- Innovative optical shaping system greatly enhances sample ionization efficiency and improves spectral peak quality.
- Titanium mass analyzer reduces ion flight interference for more accurate results.
- Immediate detection after injection, completing the analysis of 96 samples in just a few minutes.
- Comprehensive database with over 5,000 microbial species and more than 16,000 strains, regularly updated for users, with additional valuable information and resources for gene, biochemical, and drug sensitivity analysis.
- Calibration and quality control reagent kits available, providing convenience, time-saving, and no biological safety risks, supporting ISO 15189 accreditation for laboratories.
In 2019, Autof Ms Series entered the overseas market and has been sold to more than ten countries, including Poland, Greece, Italy, and France. Its performance and reliability have been widely recognized by international customers.