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23 Mar 2025

VivaChek Proudly Sponsors the 2025 Linping Half Marathon, Promoting Smart Training with Lactate Analysis

VivaChek Sponsors the 2025 Linping Half Marathon24th March 2025 – VivaChek is proud to sponsor the 2025 Linping Half Marathon, a premier event that united thousands of runners in E-Fashion Town. As part of our commitment to sports science and athlete wellness, we introduced the  VivaChek Lactate Analyzer , a cutting-edge tool designed to enhance endurance training and recovery strategies.Introducing the VivaChek Lactate AnalyzerThe VivaChek Lactate Analyzer revolutionizes the way athletes m...

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16 Mar 2025

New IVDR Self-Testing Certificate for Strep A Rapid Test!

We are excited to announce that Greylynx, a subsidiary of VivaChek, has successfully received the In Vitro Diagnostic Regulation (IVDR) self-testing certificate for its Strep A Rapid Test. This certification ensures our commitment to providing an accurate, reliable, and user-friendly diagnostic solution for early detection.The IVDR (EU 2017/746) establishes a robust, transparent, and sustainable regulatory framework to enhance clinical safety and expand market opportunities for healthcare profes...

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13 Feb 2025

VivaChek Receives Medical Device Registration for hCG Pregnancy Rapid Test in Brazil

VivaChek™ Biotech (Hangzhou) Co., Ltd., a leading global provider of medical diagnostic solutions, is pleased to announce that its VivaDiag™ hCG Pregnancy Rapid Test has received official medical device registration approval in Brazil. This milestone highlights the company's commitment to expanding its presence in the international market, particularly in Latin America.The VivaDiag™ hCG Pregnancy Rapid Test is a fast and accurate tool designed to detect the presence of human chorioni...

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09 Feb 2025

VivaChek Celebrates Successful Participation at Medlab Middle East 2025

VivaChek proudly showcased its cutting-edge innovations at Medlab Middle East 2025, one of the world's leading healthcare and laboratory exhibitions.Renowned for its comprehensive portfolio of high-quality medical devices, including blood glucose monitoring systems, point-of-care analyzers, PCR kits, and rapid diagnostic tests, VivaChek garnered significant interest from healthcare professionals, distributors, and partners. The event underscored VivaChek's dedication to advancing healthcare thro...

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23 Oct 2024

BioSieve™ Fentanyl FIA Home Test Kit and BioSieve™ Toxismart FIA Reader Get FDA Approval for OTC Use

We are proud to announce that VivaChek a leading innovator in diagnostic solutions, has achieved a significant milestone. Our BioSieve™ Fentanyl FIA Home Test Kit and BioSieve™ Toxismart FIA Reader have received FDA approval for over-the-counter (OTC) use, making them the first-ever devices of their kind to reach this milestone.This FDA approval paves the way for individuals and families to access reliable, at-home testing solutions to detect fentanyl, a substance at the center of a growing publ...

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09 Oct 2024

VivaChek Opens New Headquarter Campus, Marking a Milestone in Company Growth

On October 10, 2024, VivaChek celebrated a significant milestone with the official inauguration of its new headquarters campus located at 17 Wuzhou Road, Linping District, Hangzhou China. This marks an important step in the company's continuous growth and development within the in vitro diagnostics industry.The new campus spans three buildings with a total construction area of 37,600 square meters, providing a modern and expansive space for VivaChek’s operations, research, and innovation. The fa...

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18 Aug 2024

VivaChek Biotech Achieves FDA Clearance for Three Innovative Glucose Meters

We are excited to announce that VivaChek Biotech has received FDA clearance for three of its glucose meters featuring advanced FAD enzyme technology. This key milestone underscores the company’s steadfast commitment to driving innovation and maintaining the highest quality standards in healthcare.The FDA clearance covers the following devices:VivaChek™ FAD Blood Glucose Monitoring SystemVivaChek™ FAD Smart Blood Glucose Monitoring SystemVivaChek™ FAD Sync Blood Glucose Monitoring SystemThese dev...

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19 Jun 2024

VivaChek Achieves 510(k) Clearance for BioSieve™ Fentanyl FIA Test Kit and BioSieve™ Toxismart FIA Reader

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. Desi...

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19 Feb 2024

VivaChek's VivaDiag Glycosylated Hemoglobin Test Kit Receives IVDR Certification

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 lo...

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24 Jan 2024

VivaChek Achieves Milestone with IVDR Certification for Two Advanced Glucose Monitoring Systems

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 a...

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15 Jan 2024

Vivachek launches a new Lactate Analyzer globally

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 Vi...

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18 Dec 2023

VivaChek received FDA 510(K)clearance for VivaChek Link Plus 4G Blood Glucose Monitoring System

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 22th. 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 re...

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26 Nov 2023

VivaChek Triumphs at Medica 2023, Unveiling Cutting-Edge Solutions for Chronic Disease Management and Diagnostics

Düsseldorf, Germany - VivaChek has emerged triumphant at Medica 2023, unveiling a stellar array of groundbreaking products dedicated to revolutionizing chronic disease management and diagnostic testing. The global healthcare innovator took center stage with a showcase that included the VivaChek Pro Multi-Functional Monitoring System, a 4G-enabled home-use multi-function monitoring system, the VivaDiag FIA Analyzer VIM2000, Drug of Abuse Urine Tests, and a cutting-edge lactate analyzer, reaffirmi...

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26 May 2022

VivaChek launches Five New Products for Monkeypox Virus Test

On May 18, 2022, a U.S. resident was tested positive for monkeypox after returning to the U.S. from Canada, which has attracted extensive attention. In most cases, Monkeypox infection is only found in Africa, thus this case is presumably linked to international travel or imported animals. The Centers for Disease Control and Prevention (CDC)[1] is also tracking multiple clusters of monkeypox infection that have been reported from early to mid-May in Europe and North America.According to the World...

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09 Feb 2021

VivaDiag™ SARS-CoV-2 IgM/IgG rapid test identified as one of the top-performing COVID-19 antibody POC tests

Feb 10th, 2021, NSF International published results indicating that " Researchers have identified top-performing COVID-19 POC tests ","After screening more than 1,100 independently assessed, point-of-care COVID-19 tests, researchers at NSF International and Novateur Ventures have identified 5 direct (antigen/RNA) tests for detection of acute infection and 6 indirect (antibody) tests for detection of prior infection that meet the recently published World Health Organization (WHO) "desirable" Targ...

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09 Jul 2020

VivaDiag™ SARS-CoV-2 IgM/IgG Rapid Tests have been evaluated by FIND and KU Leuven

Hangzhou & San Diego, July 10, 2020 - in-vitro diagnostic manufacturer VivaChek announced today that the VivaDiag™ SARS-CoV-2 IgM/IgG Rapid Tests have been evaluated by FIND and KU Leuven Belgium recently.On the 13 th of March 2020, FIND launched an expression of interest (EOI) process for SARS-CoV-2 antigen or antibody tests developers to have their immunoassays evaluated independently by standardized protocols. The EOI was closed on the 20th of March 2020, with over 100 submissions receive...

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05 Mar 2020

VivaChek donates 5,040 pcs COVID-19 IgM/IgG rapid test devices to Italy

Hangzhou March 6, 2020 - In-vitro diagnostic manufacturer VivaChek announced today that they have received confirmation letters from the Regional Crisis Centers of Health Department (Assessorato alla sanità-Unità di Crisi) in Italy, to accept and appreciate the donation of 5,040pcs VivaDiag COVID-19 IgM/IgG rapid test devices. Those rapid test devices will be used to help the diagnosis of the new corona virus infection. Compared with Nucleic Acid Test, this kind of IgM/IgG rapid test is much mor...

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23 Dec 2018

The VivaChek™ 's 6 models BGMS were cleared by the US FDA

FDA (Food and Drug Administration) is the international medical device audit authority, authorized by the US Congress, the federal government, specializing in food and drug management of the highest law enforcement agencies. VivaChek Ino Smart VivaChek Ino Sync VivaChek Ino Sound VivaChek Ino Plus VivaChek Ino Sound Simple VivaChek Ino Sound BrightBlood Glucose Monitoring System got approved by the USA FDA.Following attached the 510k certificate ...

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23 Apr 2017

The VivaChek™ Ino Blood Glucose Monitoring System was cleared by the USA FDA

FDA (Food and Drug Administration) is the international medical device audit authority, authorized by the US Congress, the federal government, specializing in food and drug management of the highest law enforcement agencies.VivaChek™ Ino Blood Glucose Monitoring System got approved by USA FDA.Hereby attached the certificate....

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29 Dec 2016

VivaChek Glucose Monitoring Systems are showing good during inpection of the Minister of Health Moldova

The Republic of Moldova, referred to as "Moldova", is located in the landlocked country of south-east Europe, bordering Romania and Chisinau,Moldova is a former Soviet republic, independent in 1991, is now a member of the Commonwealth of Independent States.A few days ago the VivaChek Glucose Monitoring Systems were inspected by the Minister of health of Moladova and the local state TV broadcast the video during prime-time.VivaChek Ino won the tender of Ministry of Health of Moldova,and the tende...

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27 Nov 2016

Glucowell App Free download from Google Play & Apple Store

Glucowell™ -----Diabetes Management AppSync               Automatically sync test results from VivaChek Bluetooth glucose meters.Control         GlulcoWell App can track and analyzeglucose, food, meds and sports data, helps you control                          diabetes more effectively.Share            The overall glucose report including logbook...

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16 Oct 2016

VivaChek Ino evaluation is published on the JDST!

VivaChek™ Ino evaluation by IDK Germany is now published on the Journal of Diabetes Science and Technology!The Journal of Diabetes Science and Technology (JDST) is a bi-monthly, peer-reviewed scientific journal published by the Diabetes Technology Society.JDST covers scientific and clinical aspects of diabetes technology including glucose monitoring, insulin and metabolic peptide delivery, the artificial pancreas, digital health, precision medicine, social media, cyber security, software for mod...

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10 Jul 2016

VivaChek is listed on Drugs Tariff NHS (UK)

The National Health Service (NHS) is the publicly funded healthcare system for the United Kingdom. It is the largest and the oldest single-payer healthcare system in the world. Primarily funded through the general taxation system and overseen by the Department of Health, the system provides healthcare to every legal resident in the United Kingdom, with most services free at the point of use. Some services, such as emergency treatment and treatment of infectious diseases are free for everyone, in...

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