Recently, seven staining solutions developed by the company for pathological testing have successfully obtained Class I medical device filing certificates issued by the National Medical Products Administration. The successful completion of this filing marks a significant breakthrough in the company's product development and compliance system construction within the in vitro diagnostic reagent field, further enriching its product portfolio for pre-processing in pathological diagnosis.

The seven registered products are specialized staining reagents for pathology, covering fundamental staining categories commonly used in histological and cytological examinations. They include Masson's trichrome stain, iron stain, Papanicolaou stain, mucin carmine stain, Helicobacter pylori stain, Liu's stain, and Wright's stain. As Class I medical devices, these staining solutions serve as indispensable foundational reagents in pathological diagnosis, with their quality directly impacting slide preparation outcomes and subsequent diagnostic accuracy. Specifically, these solutions possess distinct targeted applications and significant clinical value in pathological diagnosis:

Masson's trichrome stain: Primarily used to clearly visualize collagen fibers (blue/green) and muscle fibers (red). It is crucial in diagnosing kidney diseases (e.g., glomerulonephritis, renal interstitial fibrosis), liver diseases (assessment of cirrhosis), determining the degree of tumor interstitial fibrosis, and cardiovascular diseases (e.g., myocardial fibrosis). It aids in evaluating tissue damage repair and the extent of fibrotic lesions.

‌ Iron Stain (Prussian Blue Reaction):‌ Specifically detects trivalent iron ions in tissues. Serves as the gold standard for diagnosing hemochromatosis (iron overload disease), hemolytic anemia, iron overload after repeated transfusions, and iron deposition in chronic liver disease. Indispensable for etiological diagnosis and monitoring treatment efficacy in related conditions.

‌ Papanicolaou Stain: ‌‌The standard staining method for gynecological cervical/vaginal exfoliative cytology (cervical cancer screening), also widely used for non-gynecological exfoliative cytology examinations of sputum, urine, and body cavity effusions. It clearly displays nuclear details and cytoplasmic differentiation, playing a crucial role in the early detection of precancerous lesions (e.g., cervical intraepithelial neoplasia) and malignant tumors (e.g., squamous cell carcinoma, adenocarcinoma).

Mucin Carmine Stain: Specifically stains neutral mucus and mucin (appearing red). Commonly used for diagnosis and differential diagnosis of gastrointestinal epithelial tissues (e.g., gastric mucosal intestinal metaplasia, goblet cells), ovarian mucinous tumors, breast mucinous carcinomas, thyroid tumors, and other sites, aiding in identifying mucus-producing adenocarcinomas or cell types.

Helicobacter pylori staining solutions: (e.g., modified Giemsa, WS silver staining) specifically designed for morphological visualization of Helicobacter pylori in gastric mucosal biopsy specimens. These are essential tools for diagnosing Helicobacter pylori infection (closely associated with chronic gastritis, peptic ulcers, gastric mucosa-associated lymphoid tissue lymphoma, and gastric cancer development), guiding clinical antimicrobial therapy.

‌Reissner's Stain:‌ One of the standard staining methods for blood and bone marrow cytology, particularly suited for detailed morphological examination of blood cells. It plays a fundamental role in diagnosing and classifying various anemias, leukemias, infectious diseases (e.g., malaria parasites, Bartonella), and platelet disorders.

Rice's Stain: The most commonly used rapid staining method for blood and bone marrow cytology. Widely applied in routine examinations of peripheral blood smears and bone marrow smears, it enables preliminary assessment of the quantity and morphology of red blood cells, white blood cells, and platelets. It serves as the preferred screening tool for diagnosing anemia, infections, leukemia, and other hematological disorders.

The company strictly adheres to relevant regulations and standards in R&D and production control, ensuring each staining solution exhibits excellent stability, consistency, and safety. This meets the urgent demand of pathology departments across all levels of medical institutions for high-quality, highly reliable staining reagents in the precise diagnosis of various diseases.

The successful registration of this staining solution series represents the collaborative achievement of the company's R&D, quality assurance, and regulatory teams. We are committed to providing reliable and efficient pre-processing solutions for pathological diagnosis, offering precise staining tools tailored to the diagnostic needs of different diseases to enhance the efficiency and reliability of pathological examination results. The company is actively preparing for the market launch of this product series and will concurrently provide professional technical support and application guidance to ensure users can fully leverage the product's performance.

The acquisition of these seven staining solution registration certificates not only strengthens our product portfolio in fundamental pathology reagents but also lays a solid foundation for developing more complex diagnostic products. We will continue to focus on clinical diagnostic needs, refine our in vitro diagnostic product line, and continuously enhance our technical capabilities and service standards to contribute to the advancement of precision medicine.