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13

2024

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11

Good News | Han Yao Welcomes a New Partner—Nova


Description of agency authority:

(It is the prime+ for biopharmaceutical companies nationwide.)

Hanyao will remain committed to its consistent service philosophy, upholding the values of “integrity, altruism, and gratitude.” With customer satisfaction as our top priority, we will provide biopharmaceutical companies with the high-standard Nova Prime Plus, and ensure comprehensive services—including training, maintenance, repair, and spare parts supply—throughout the entire process.

Background of Nova Biomedical Company

1.1 NOVA’s History and Achievements

- Nova Biomedical, a U.S. company, is the largest private manufacturer of in vitro diagnostic equipment in the United States and has enjoyed nearly five decades of stable and mature development.

- Since 1977, the company has launched over 117 models of analytical instruments, obtained more than 105 FDA product certifications, and established partnerships with over 30 OEMs.

- Nova Biomedical, driven by technological innovation, is a global leader in whole-blood biosensor technology.

1.2 Quality Certification

- Nova products hold multiple quality certifications, including FDA registration, ISO 9001:2000, compliance with ISO 13485:2003, and CE Mark IVDD compliance.

Nova Prime Plus Product Introduction

2.1. Comprehensive Monitoring Parameters

Prime Plus provides comprehensive critical care monitoring parameters, including pH, PCO2, PO2, SO2%, Hct, tHb, Na+, K+, Cl-, Ca++, Mg++, BUN, Creat, Glu, Lac, and more.

In biopharmaceutical process monitoring, these parameters play a crucial role:

- pH: The pH of cell culture media affects cell growth and metabolism; maintaining an appropriate pH range is essential for cell growth and proliferation.

- PCO 2 Partial pressure of carbon dioxide. During cell culture, monitoring PCO2 can help assess the carbonate balance under cell culture conditions.

- PO 2 Partial pressure of oxygen. Cells require sufficient oxygen for metabolism and growth, and monitoring PO2 can ensure that cells are in an appropriate oxygen environment.

- Na+, K+, Cl-, Ca++, Mg++: These ions are essential for cell growth and metabolism, and monitoring their concentrations helps maintain the stability of the intracellular and extracellular environments.

- Glue: Glucose. Cells require glucose as an energy source, and monitoring glucose concentration ensures that cells have sufficient energy for growth and metabolism.

- Lake: Lactic acid is a metabolic byproduct produced by cells, and changes in its concentration can reflect the cells’ metabolic status and the suitability of the culture conditions.

2.2 Technical Advantages

- Utilizes whole-blood biosensor technology to provide rapid and accurate test results.

- It features a separate electrode card and reagent kit design, making consumable replacement simple and convenient. Additionally, it employs an RFID and EEPROM system to record consumable-related data, facilitating user management and usage of consumables.

- Equipped with a fully automated liquid quality control (LQC) + supplementary quality monitoring (SQM) quality control system, providing comprehensive and compliant quality control.

- The operation process has been simplified, and users can complete the analysis in just a few simple steps.

- The device supports multiple sample injection modes and does not require additional adapters.

2.3 Technical Parameters

Measurement item

Concentration range

pH

6,500–8,000

pO2

0–800 mmHg (0.0–106.7 kPa)

pCO2

3.0–200 mmHg (0.4–26.7 kPa)

Na+

80–200 mmol/L

Hct

12%–70%

K+

1.0–20.0 mmol/L

CI-

50-200 mmol/L

iCa

0.10–2.70 mmol/L (0.40–10.8 mg/dL)

Glue

15–500 mg/dL (0.8–28 mmol/L)

Lake

0.3–20.0 mmol/L (2.7–178.0 mg/dL)

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