VivaChek Point of Care Testing Solutions in 120+ Countries

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VivaChek Point of Care Testing: A Diversified Diagnostics Portfolio Built on Accessible Health Management

VivaChek Biotech (Hangzhou) Co., Ltd., founded in August 2013 and headquartered at Building 2, No.17 Wuzhou Road, Donghu Street, Linping District, Hangzhou, Zhejiang, People's Republic of China, has grown into a diversified point of care testing (POCT) organization. The company operates under the development concept of "making health management accessible" and has built what it describes as an ecosystem of "chronic disease management + rapid diagnosis + digital medical." Today, VivaChek's products are available in over 120 countries across the globe, supported by a network of affiliated entities including VivaChek Laboratoires, Inc. in Wilmington, Delaware, USA; Vivachek Diagnostics Inc. in Sacramento, California, USA; VivaChek Life Care in Chennai, India; and branch operations in Singapore and India.

Corporate Positioning Rooted in Real-World Diagnostic Needs

VivaChek's strategic positioning responds to a well-documented industry pain point: healthcare providers and patients require accessible health management, accurate point-of-care testing, simplified multi-parameter monitoring, and connected digital data sharing for chronic disease and rapid diagnosis. As a high-tech enterprise and POCT product manufacturer, VivaChek has structured its offerings to address these needs directly, positioning itself as a globally trusted smart POCT provider.

A Comprehensive Point of Care Testing Portfolio

VivaChek's product matrix spans 68 products and services organized into distinct diagnostic categories, each addressing a specific segment of patient and professional testing needs.

Blood Glucose and Multi-Function Monitoring

At the core of VivaChek's offering is its blood glucose and multi-function monitoring line, which includes the VivaChek Neo System, VivaChek Link Plus, VivaChek Ino Sound, VivaChek Fad Smart, VivaChek Ino, and VivaChek Eco, among others. The VivaChek Neo System is engineered to quantitatively measure glucose concentrations in fresh whole blood, with a hematocrit range of 0-70% that supports testing across diverse patient profiles, including neonates, pregnant women, and patients with anemia. The system offers optional Auto Sync Bluetooth for seamless data transfer, large memory storing up to 1,000 test results with date and time, a 40 mm × 40 mm display screen, and dimensions of 96 mm × 58.5 mm × 24 mm, powered by a single CR 2032 3.0V coin cell battery.

The VivaChek X multi-function monitoring system extends this capability further, functioning as a three-in-one device that tests glucose, ketone, and uric acid levels within a single unit. It features optional Bluetooth data transfer, storage for 1,000 results with time and date, a strip ejector designed to reduce contamination risk, and compatibility with VivaChek Ino Blood Glucose, VivaChek Fad Blood Glucose, VivaChek Blood Ketone, and VivaChek Uric Acid Test Strips. Both the VivaChek Ino and VivaChek Eco glucose meters meet DIN EN ISO 15197:2013 requirements, an international standard for glucose meter accuracy.

Immunofluorescence FIA Products

VivaChek's immunofluorescence line centers on the VivaDiag Multifunction Meter (Model: VIM220H), which works with VivaDiag FIA Test Kits to deliver quantitative or qualitative measurement of multiple parameters using fluorescence immunochromatography and photoelectric detection. This platform supports rapid results from tiny samples within a few minutes, enabling test kits across diabetes, cardiac markers, renal function, hormone, drug of abuse, tumor markers, inflammation, autoimmune, and infectious disease categories. Specific kits include the T3 VivaDiag Triiodothyronine Test Kit, CAL VivaDiag Calprotectin Test Kit, fT3 VivaDiag Free Triiodothyronine Test Kit, SAA VivaDiag Serum Amyloid A Protein Test Kit, MOP VivaDiag Morphine Test Kit, and the cTnI/CK-MB/MYO VivaDiag Cardiac Combo Test Kit, each validated for a defined sample type such as human serum, plasma, whole blood, feces, or hair.

Molecular Diagnostics and Lateral Flow Testing

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The VivaDiag Molecular System is built on VivaChek's proprietary LAMP-RADAR technology, working with nucleic acid detection reagents to deliver qualitative detection of nucleic acid in human or environmental samples. This system is complemented by a lateral flow rapid test line covering respiratory virus, hepatitis virus, sexually transmitted, gastrointestinal, and cardiac marker testing, alongside PCR kits and instruments.

Hemoglobin, Coagulation, and Chemistry Testing

VivaChek also offers a Hemoglobin & Lipid Testing System and a Coagulation and Chemistry Testing System, including the Coagulation - MC100 and Chemistry-MS100 platforms, along with handheld devices for measuring cholesterol, coagulation, and hemoglobin.

Veterinary Diagnostics

Recognizing diagnostic needs beyond human health, VivaChek's veterinary line includes the Veterinary Coagulation and Chemistry Combo, built on a centrifugal microfluidic platform. This solution delivers coagulation results in 15 minutes or less and chemistry results in 13 minutes or less, using lyophilized reagents stored at 2-8°C with a 12-month shelf life. Sample volumes are set at 140 μL for chemistry and 180 μL for coagulation. The veterinary portfolio also covers blood glucose, blood ketone, and milk ketone monitoring systems.

VivaGuard Home Care and Home Care Devices

For home health management, the VivaGuard line includes blood pressure monitoring systems, infrared forehead thermometers, digital thermometers, mesh nebulizers, and AC compressor nebulizers. VivaChek's standalone infrared forehead thermometers deliver a 1-second test time with accuracy of ±0.2°C (±0.4°F) and jumbo LCD displays, while digital thermometers provide oral, rectal, and axillary measurement with accuracy of ±0.1°C (±0.2°F).

Quality Systems and Regulatory Alignment

VivaChek's quality management system is aligned with multiple international frameworks, including FDA 510(k) clearance, European Union CE marking, China NMPA approval, EN ISO 13485, China GMP compliance, the international ISO system, and FDA QSR (Quality System Regulations). The VivaChek Ino and VivaChek Eco glucose meters additionally comply with DIN EN ISO 15197:2013, reinforcing the accuracy standards applied across the glucose monitoring line.

Global Footprint and Market Presence

VivaChek's global footprint extends from its Hangzhou headquarters and Shaoxing, Zhejiang Province manufacturing facility to operations in the United States, India, and Singapore. Since its founding, VivaChek glucose meters were sold in more than 30 countries within the first year after launch, and the company has participated in global medical exhibitions including FIME, CMEF, MEDICA, Arab Health, EASD, Medtrade, MEDICAL FAIR THAILAND, SFD, and MEDIALAB Asia Pacific between 2014 and 2019, including exhibition support for World Diabetes Day awareness. Today, VivaChek states that its blood glucose meters have helped millions of diabetic patients worldwide, with products reaching healthcare professionals, diabetic patients, home users, and veterinary professionals across more than 120 countries.

A Connected Approach to Diagnostics

Across its portfolio, VivaChek incorporates optional Bluetooth data synchronization on select devices, allowing test results to transfer and sync with compatible devices as part of its digital medical ecosystem. Combined with its breadth of testing categories—from blood glucose and immunoassay to molecular diagnostics, veterinary testing, and home care—VivaChek Biotech (Hangzhou) Co., Ltd. presents itself as a manufacturer working to make point of care testing accessible, connected, and adaptable to diverse healthcare settings worldwide.

https://www.vivachek.com/poct.html
VivaChek Biotech (Hangzhou) Co., Ltd.

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