Shanghai ZJ Bio-Tech’s HCV Nucleic Acid Test Kit Receives NMPA Approval

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China-based molecular diagnostic reagent specialist Shanghai Liferiver Bio-Tech Co., Ltd (SHA: 688317) has announced receiving Category III medical device license from the National Medical Products Administration (NMPA) for its hepatitis C virus (HCV) nucleic acid test kit (fluorescent PCR method). This product is designed for the quantitative detection of HCV RNA in human serum and plasma samples.

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Advanced Detection Technology
The kit employs a high-sensitivity hepatitis C nucleic acid detection scheme with a sensitivity of 15IU/mL. This innovative approach significantly enhances detection sensitivity compared to conventional reagents, shortens the detection window period, and enables precise control of the critical time for diagnosis and treatment of HCV-infected individuals.-Fineline Info & Tech

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