VivaChek Biotech (Hangzhou) Co., Ltd

Level 2, Block 2, 146 East Chaofeng Rd., Yuhang Economy Development Zone
Hangzhou, 
China
http://www.vivachek.com

• Booth: 264

VivaChek Biotech was founded in Hangzhou, China in 2013 as a manufacturer of blood glucose monitoring systems, Drug of Abuse testing, and other POCT products. Since then, we have established ourselves as a reliable and rapidly growing company with a presence in over 120 countries worldwide. We strive to make healthcare more accessible and convenient through our point-of-care testing solutions.

 Press Releases

• VivaChek Achieves 510(k) Clearance for BioSieve™ Fentanyl FIA Test Kit an (Jun 25, 2024)

  We are excited to announce that VivaChek has achieved a significant milestone with the US FDA 510(k) clearance of our BioSieve™ Fentanyl FIA Test Kit and BioSieve™ Toxismart FIA Reader. This groundbreaking approval marks the first of its kind in the United States, setting a new standard in fentanyl detection technology.

  Our BioSieve™ products leverage advanced Fluorescence Immuno Assay (FIA) technology, offering unparalleled sensitivity in fentanyl detection with a threshold of just 1 ng/mL. Designed for portability and ease of use, the BioSieve™ Toxismart FIA Reader features a handheld Bluetooth reader, rechargeable lithium battery, and provides fast results within 5 minutes. Weighing only 0.36 lbs, this compact device also supports custom configurations to meet diverse testing needs.

  This approval is a testament to VivaChek's commitment to innovation and excellence in medical technology. We are proud to lead the way in portable, precise fentanyl detection, enhancing safety and accuracy in drug testing. For more information, please contact Ashish Parikh at ashish.parikh@vivachekdx.com and Paul Johnson at paul.johnson@vivachekdx.com.

• VivaChek received FDA 510（K）clearance for VivaChek Link Plus 4G Blood G (Jun 25, 2024)

  We are excited to announce a significant milestone for VivaChek: our revolutionary VivaChek Link Plus Blood Glucose Monitoring System received FDA 510(k) clearance on December 19th. This achievement marks a substantial advancement in diabetes management technology, signifying a noteworthy leap forward in our commitment to innovation and healthcare excellence.
  
  VivaChek Link Plus Monitoring System combines the accuracy of glucose meters with the power of 4G real-time data transmission. It offers real-time data monitoring for timely management, remote monitoring for support and treatment adjustments, enhanced safety with alerts, comprehensive data analysis, simplified management, improved communication with healthcare providers, and seamless integration with digital platforms, empowering individuals with better diabetes control and personalized care.
  
  The VivaChek Link Plus Blood Glucose Monitoring System represents a significant step forward in diabetes care, providing individuals with the tools they need for better control, personalized care, and improved overall well-being.

• Vivachek launches a new Lactate Analyzer globally (Jun 26, 2024)

  VivaChek is proudly announces the global launch of the VivaChek Lactate Analyzer, a cutting-edge device meticulously crafted to elevate athletic performance.

  VivaChek Lactate Analyzer redefines the landscape of sports science, providing athletes with a powerful tool to precisely monitor lactate levels. This innovation facilitates performance optimization, recovery assessment, and the ability to tailor fitness regimes based on individual lactate responses.
   

  Key Features:

  Precision at its Core: The VivaChek Lactate Analyzer delivers unparalleled accuracy in lactate measurement, providing athletes with real-time insights crucial for optimizing their performance.

  Seamless User Experience: Designed with athletes in mind, the device ensures ease of use, enabling users to effortlessly incorporate lactate testing into their training routines.

  Bluetooth Connectivity: The device comes equipped with state-of-the-art Bluetooth connectivity, allowing seamless data transfer to mobile devices. This feature empowers athletes and coaches with instant access to performance metrics, fostering informed decision-making.
  It is available on www.vivachekonline.com now. 

• VivaChek's VivaDiag Glycosylated Hemoglobin Test Kit Receives IVDR Certific (Jun 26, 2024)
  VivaChek is proud to announce that its VivaDiag Glycosylated Hemoglobin Test Kit has received certification under the In Vitro Diagnostic Regulation (IVDR). This certification, granted in February 2024, underscores our commitment to delivering accurate and reliable diagnostic tools for healthcare professionals.
  The VivaDiag Glycosylated Hemoglobin Test Kit is designed for the quantitative measurement of glycated hemoglobin (%HbA1c) in human venous whole blood samples. It is intended to monitor long-term glycemic control in individuals previously diagnosed with diabetes mellitus. This innovative in-vitro diagnostic system utilize fluorescence immunoassay technology to provide precise and consistent results, enabling healthcare professionals to make informed decisions about patient care.

  The IVDR certification is a testament to our dedication to meeting the highest standards of quality and safety in the development of our diagnostic products. We are proud to offer a comprehensive range of solutions that empower healthcare professionals to deliver the best possible care to their patients.

  For more information about the VivaDiag Glycosylated Hemoglobin Test Kit and our other innovative diagnostic solutions, please visit our website or contact us directly.

• VivaChek Achieves Milestone with IVDR Certification for Two Advanced Gluco (Jun 26, 2024)
  VivaChek proudly announces the successful IVDR certification for two of its state-of-the-art glucose monitoring systems. Achieving this milestone on January 25th, 2024, underscores VivaChek's unwavering commitment to delivering accurate and high-quality healthcare solutions for effective diabetes management.

  The IVDR certification validates the precision and reliability of VivaChek's glucose monitoring systems, reinforcing the company's dedication to maintaining the highest standards of quality and safety. This certification enhances trust in VivaChek's commitment to providing top-tier healthcare solutions.

  With IVDR certification in place, VivaChek is poised to further elevate its presence in the European market, offering advanced glucose monitoring systems that contribute to improved diabetes management through precision and quality.