Sysmex Corporation (HQ: Kobe, Japan; Chairman and CEO: Hisashi Ietsugu) received regulatory approval on December 9, 2019 from China’s National Medical Products Administration (NMPA) for LYNOAMP™ BC, an in vitro diagnostic reagent. Our system to test for breast cancer lymph node metastasis using the OSNA™ method has received Class III1 regulatory approval as the first product for lymph node metastasis testing using a molecular biological technique.
Details of Regulatory Registration in China of the RD-100i Gene Amplification Detector | |||
Name: | RD-100i Gene Amplification Detector (In Chinese: 基因扩增分析仪) | ||
Classification: | Class III | ||
Registration renewal: | April 15, 2019 | ||
Target use: | This product is based on reverse transcription-loop-mediated isothermal amplification (RT-LAMP) technology. Used in combination with an appropriate reagent, this product is used for the qualitative detection of CK19 mRNA in human lymph node samples. | ||
Registration number: | 国械注进20193221975 | ||
Product photo: |
Details of Regulatory Registration in China of the LYNOAMP™ BC | |||
Name: | LYNOAMP™ BC (In Chinese: 细胞角蛋白19核酸(CK19 mRNA)检测试剂盒(环介导等温核酸扩增法)) | ||
Classification: | Class III | ||
Registration: | December 9, 2019 | ||
Target use: | This product is used in the semi-quantitative detection of cytokeratin 19 mRNA (CK19 mRNA) in sentinel lymph nodes removed during breast cancer surgery. | ||
Registration number: | 国械注进20193400611 | ||
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Terminology | |||
1 | Products categorized as Class III in China: China’s National Medical Products Administration (NMPA) classifies medical devices and pharmaceuticals from Class I to Class III, based on their risk level. Class III indicates a relatively high-risk level, and items with this classification must be managed stringently in accordance with special measures, and their safety and efficacy must be guaranteed. |
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2 | H&E staining test: Hematoxylin and eosin (H&E) is one of the most fundamental and important staining methods for pathological tissue. |