Good news! RocgeneArchimed series of medical fluorescence quantitation family has made another important breakthrough - the core product Archimed X Pro medical fluorescence quantitative PCR instrument has officially won the national medical device class III registration certificate! This is not only a key expansion of the Archimed® X series product line, but also marks that the product has passed the highest national standards and strict certification in terms of quality control and clinical applicability, injecting stronger impetus into clinical diagnosis and scientific research applications, and further enriching the product selection of medical-grade fluorescence quantitative testing!

three types of certificates support

the "hard-core pass" of medical-grade quality

After several years of R&D and polishing and multiple rounds of verification, Archimed X Pro finally successfully passed the strict review of the State Medical Products Administration and successfully won the third type of registration certificate. This achievement is not only a continuation of Rocgene's technical accumulation in the field of medical fluorescence quantitative PCR, but also an adherence to the concept of "quality-based" - from core component selection to GMP-level control in the production workshop, from laboratory performance testing to multi-center clinical verification, every link is guided by clinical needs and national standards as the bottom line to ensure that the whole process of products from factory to clinical application is stable and reliable, and forms a hard-core guarantee of quality homology with the certified products in the series.

This certification is not only an authoritative recognition of the strength of Archimed X Pro products by the national regulatory authorities, but also means that the product can officially enter the clinical diagnosis scenario of medical institutions at all levels, providing compliance and accurate testing support for key areas such as viral nucleic acid testing, infectious disease screening, and tumor marker detection.

01

Upgrade and innovation: not only surpass, but also understand clinical needs

As an upgraded masterpiece of the Archimed® X series, Archimed X Pro inherits the core advantages of the family and innovates in an all-round way for the pain points and difficulties in clinical applications , so that the three core advantages of "accuracy, efficiency and convenience" are more prominent.

⪼More accurate: independent physical temperature control partitioning, intelligent regulation of temperature rise and fall rate, shorter amplification time, to meet the "personality" needs of different reagent systems.

⪼More efficient: breaks the scanning bottleneck and realizes ultra-fast fluorescence detection (standard speed 3s/96 wells, extreme speed 1s/96 wells), and the detection is more "fast";

⪼More convenient: compatible with 0.1mL and 0.2mL eight-row consumables and semi-skirt, no skirt, etc., consumables can be selected "freely".

>02

Clinical adaptation optimization: both versatility and scalability are improved

Archimed X Pro has been fully upgraded in terms of operational versatility and expandability. The instrument is equipped with a 12-inch touch screen, equipped with a newly upgraded intelligent operating system, which supports one-click call of experimental programs, automatic data analysis and report generation, and human-computer interaction is more friendly, and novice operators can also get started quickly, reducing laboratory training costs. Focus on the future to meet the performance needs of fluorescence quantitative PCR instruments in the next 10 years.

⪼More heavy: 6-color fluorescence detection channel as standard, 8-color fluorescence channel can be upgraded (2 customized channels), and meets the needs of "now" and "future" at the same time;

⪼ Smarter: The terminal can easily realize the interconnection with a variety of ports, support expansion, and facilitate the integration of department information more "intelligent";

⪼More intimate: System settings, voice, scanning and other modules are more in line with the usage habits of contemporary people, and they run "freely" like their own mobile phones.

family empowerment - Archimed series

builds full-scenario solutions

The addition of Archimed X Pro further completes the Archimed® series of medical fluorescence quantitation product matrix. At present, the series has covered a variety of products with different throughput and different application scenarios, from routine screening in primary medical institutions to accurate diagnosis in tertiary hospitals, from emergency detection of public health emergencies to in-depth research in scientific research institutions, providing comprehensive customized solutions.

The original intention is like a rock

empowering life and health with innovation

Rocgene is committed to transforming new technologies in the field of life science research into clinically relevant medical research products, and developing scientific research and molecular diagnostic products with independent intellectual property rights. The Archimed X Pro has obtained three types of registration certificates, which is a continuation of the dual strength of technology research and development and quality control, and is an important step for enterprises to practice the vision of "making accurate testing within reach", so that the medical-grade product matrix of the Archimed series is more perfect.

In the future, Rocgene will continue to invest in core technology research and development, continuously enrich the product line matrix, start from clinical needs, launch more innovative and more practical testing equipment, and contribute more to the improvement of medical diagnosis level and public health security with an increasingly perfect product layout!