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安必平:HER2基因检测试剂盒(荧光原位杂交法)获得医疗器械变更注册批准

Guangzhou LBP Medicine Science & Technology: The HER2 gene testing kit (fluorescence in situ hybridization method) has obtained approval for medical instruments change registration.

Breakings ·  Dec 31, 2024 16:59

Guangzhou LBP Medicine Science & Technology announced that the company recently received the "Medical Instruments Change Registration Document" issued by the National Medical Products Administration for the HER2 gene testing kit (fluorescence in situ hybridization method). The change in content is the expected use of the product has been changed from "for in vitro qualitative detection of the amplification of the HER2 gene in 10% neutral formalin-fixed paraffin-embedded breast cancer tissue slices" to "for in vitro qualitative detection of the amplification of the HER2 gene in 10% neutral formalin-fixed paraffin-embedded breast cancer and gastric adenocarcinoma tissue slices. For gastric adenocarcinoma, it can be used for the companion diagnosis of Trastuzumab (Herceptin)."

The translation is provided by third-party software.


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