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Release time:2025-12-29As we approach the end of 2025, we warmly celebrate the successful filing approval of eight Class I medical device in vitro diagnostic reagents independently developed by our company. These include: α-Butyrophenolesterase (α-NBE) Staining Solution, Alizarin Blue Staining Solution, Flagella Staining Solution, Phosphotungstic Hematoxylin Staining Solution, Lactate Cotton Blue Staining Solution, Sirius Red Staining Solution, and Reticulum Fiber Staining Solution. These reagents cover five core clinical areas—hematopathology, microbiology, neuropathology, tumor diagnosis, and fibrosis assessment—with significant clinical implications: α-NAE and α-NBE aid in leukemia classification; Alcian blue facilitates mucinous tumor analysis; flagella stain assists bacterial identification; PTAH stain enhances neuromuscular tissue observation; lactophenol cotton blue optimizes fungal detection; Sirius red enables quantitative collagen fiber assessment, while reticular fiber staining solution strengthens tumor microstructure diagnosis. This approval demonstrates the company's technological prowess in precision medicine, significantly enhancing clinical diagnostic efficiency and contributing innovative strength to the Healthy China strategy.
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Release time:2025-12-09Recently, our company achieved a significant breakthrough in the medical device field, securing multiple approvals in one go for elastic fiber staining solution, melanin staining solution (ferrous sulfate method), acetic acid chloride AS-D naphthol esterase staining solution, Oil Red O staining solution, eosin staining solution, Giemsa staining solution, acid-fast staining solution, and calcium salt staining solution (silver nitrate method). This achievement signifies a new milestone in our company's product portfolio and technical capabilities within in vitro diagnostic reagents, particularly in the field of histochemical staining for pathological tissues. Translated with DeepL.com (free version)
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Release time:2025-11-27The company recently achieved significant R&D milestones, with its independently developed line of ten pathology staining solutions and auxiliary reagents—including cell preservation solution, Sudan black staining solution, and HE staining solution—successfully obtaining Class I medical device registration. This product series covers core pathology diagnostic processes including routine staining, special staining, and cytological examination. It provides clinicians with a comprehensive precision diagnostic solution spanning sample preservation, pathogen identification, tumor differentiation, and amyloid disease detection. This registration signifies the company's further enhancement of its product portfolio in the pathology reagent field. Future investments in R&D will continue to advance pathology diagnostic capabilities and precision medicine development.
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Release time:2025-11-14The company has recently secured seven Class I medical device registration certificates, with all approved products being specialized staining pathology solutions. This achievement significantly expands the company's product portfolio in the field of pathological diagnosis, demonstrating its capabilities in R&D and regulatory compliance systems. It will enable the company to better provide high-quality pre-processing solutions to medical institutions at all levels, thereby supporting precise diagnosis.


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