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Company Profile

Company Profile

Company Profile

Product catalog summary
Introduction
Xiamen Biotime, established in April 2008, is a high-tech enterprise specializing in the research, development, production, and sales of Point-of-Care Testing (POCT) in vitro diagnostic devices and reagents. The company is committed to quality and service, aiming to develop superior in vitro diagnostic (IVD) products that benefit global healthcare.

Research and Development
Biotime boasts a robust R&D team with over 70 intelligent engineers and has achieved numerous certifications, including 35+ CE, 65+ NMPA, and 1 FDA EUA. The company rapidly developed a COVID-19 test kit in just 25 days and has invested $50 million in supplier chain tooling. Biotime's R&D capabilities are supported by partnerships with institutions like Xiamen University and the American Sandford-Burham Medical Research Institute.

Product Range
Biotime offers a comprehensive range of products, including nine series of reagents and six technology platforms. Their offerings cover devices, reagents, and PIMS, with a focus on medical mass disposable platforms. The company has developed advanced products such as HPLC for diabetes testing and MALDI-TOF for microorganism diagnosis.

Production and Capacity
Biotime operates 80 production lines capable of producing 10 million tests per day. The company has a significant production facility with 11,000 square meters, producing up to 180 million tests monthly. Biotime has implemented various supplier chain programs to ensure efficient delivery and inventory control.

Certifications and Achievements
Biotime has obtained over 64 NMPA and 35 CE certificates for its POCT kits and instruments. The company has also received 20+ registration certificates for COVID-19 related products, including FDA EUA and CE. Biotime's products have been positively evaluated by international institutions such as Barts Health in the UK and Amiens University Medical Center in France.

Technological Platforms
Biotime has developed multiple technological platforms, including immunofluorescence, chemiluminescence, electrochemistry, HPLC, and colloidal gold. These platforms support a wide range of diagnostic tests, including cardiac markers, hormone markers, inflammatory and tumor markers, diabetes and renal injury markers, and infectious disease tests.

Conclusion
Biotime is a leading provider of POCT solutions, with a strong focus on innovation and quality. The company's extensive product range, advanced technological platforms, and robust production capabilities position it as a key player in the global IVD industry.
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Catalog excerpts

Company Profile-1

Professional POCT solution supplier About Biotime specialized in R&D, production and sales of POCT in vitro diagnostic Established in April, 2008, Xiamen Biotime is a hi-tech enterprise that devices and reagents. Biotime has always been carrying the faith of “Quality Comes From Professionalism And Service Makes The Future” . Committed to “Being Unique From Our Competitors”we have successfully , established our mature medical marketing channels during the past years. With our leading technologies, Biotime aims to develop superior IVD products which provide better solutions for heath care and benefit people all over the world. - 35+ CE, 65+ NMPA, 1 FDA EUA and more coming - 25 days to develop COVID-19 test kit Extendable Capacity and Supply Chain - 80 lines to ensure 10M tests a day - 50M$ investment on NRE tooling in supplier chain - 15 minutes delivery from VMI hub Full product coverage - 9 series of reagents - Devices, reagents and PIMS - Medical mass disposable flatform Solution Ready - Data platform and information system - Medical waste control Xiamen Biotime Biotechnology Co., Ltd. Address: 3F/4F, No. 188, Pingcheng South Road, Haicang Street, Haicang District, Xiamen, Fujian, 361026, P. R. China Tel: +86-592-688-3156 E-mail:[email protected] Advantage Strong capacity Solution provider

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Company Profile-2

After long time R&D work, Biotime has served many people with its all series qualified products, such as Cardiac/ Hormones/ Inflammation/ Tumor/ Thyroid/ Diabetes/ Renal Injury/ Infectious disease products etc. At the same time, our products have highly recognized and become more and more popular in the market. At present, we have successfully got 64+ NMPA and 35+ CE certificates for POCT kits and instruments. POCT Analyzers Full Range POCT Solution Test Reagents - Test results comes out in 3 to 20 minutes firstly launched in Chinese Immunofluorescence market. - Checking machine itself - Automatic...

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Company Profile-3

Except for immunofluorescence, Biotime also developed other platforms, including Chemiluminescence, Electrochemistry, HPLC and colloidal gold,etc. after the outbreak of COVID-19, Biotime actively tookactions to fight against with the pandemic and successfully researched and developed COVID-19 related products, During the period, Biotime has obtained 20+ registration certificates including FDA EUA, CE, CIBG and etc. Besides, we conducted performance verification in foreign authoritative institutions and got brilliant evaluation results from Barts Health in UK, Amiens University Medical Center...

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Company Profile-4

Leading Market-Driven R&D We care� Biotime is committed to understanding the needs from medical system, social care, government and all human. Our R&D team invent with science developing and market driven to cover the six major areas in not only diagnosis and medical care but also the sense of life. The thoughts out of boundary lead the innovative R&D to serve the life. - American Sandford-Burham Medical Research Institute - Xiamen University - Third Institute of Oceanography (TIO) of the Ministry of Natural Resources - More to add� Intelligent People - Over 70 R&D Engineers - Talent pool from...

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Company Profile-5

When the pandemic outbreak, Biotime is devoted to fighting the global pandemic. All In. Invest the new facilities, machines, systems so as to improve the daily Capacity Daily Output - Total 55 lines with 11,000 sq meters to produce 7M tests a day - Or 180M test in one month - A new record in the IVD industry worldwide - In house shop to produce the machine and raw materials as well System - NMPA, ISO13485 - GMP factory - ERP: K3 - Shopfloor: H3yun Cloud - BI: H3yun - Unique bar code system - Invest the NRE tooling cost in major plastic supplier - Various supplier chain program in place to ensure...

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All Xiamen Biotime Biotechnology Co., Ltd. catalogs and technical brochures

  1. POCT SOLUTION

    2  Pages

  2. FLI-100

    2  Pages

  3. Tumor Markers

    2  Pages

  4. Renal Injury

    2  Pages

  5. HbA1c

    2  Pages

  6. HLC-100

    2  Pages

  7. BIOT-YG-I

    2  Pages

  8. 25(OH)-D

    2  Pages

  9. PCT

    2  Pages

  10. Sex Hormones

    2  Pages

  11. D-Dimer

    2  Pages

  12. Ferritin

    2  Pages

  13. TSH

    2  Pages

  14. Thyroid

    2  Pages

  15. FLI-600

    2  Pages

*Prices are pre-tax. They exclude delivery charges and customs duties and do not include additional charges for installation or activation options. Prices are indicative only and may vary by country, with changes to the cost of raw materials and exchange rates.