Squamous Epithelial Cell Carcinoma (SCC) Antigen Assay Kit (Direct Chemiluminescence Method) - NMPA Registration 粤械注准20242400474
Access comprehensive regulatory information for Squamous Epithelial Cell Carcinoma (SCC) Antigen Assay Kit (Direct Chemiluminescence Method) in the China medical device market through Pure Global AI's free database. This Class II medical device is registered under NMPA registration number 粤械注准20242400474 and owned by Goldsite Diagnostics Inc.. The device was approved on March 29, 2024.
This page provides complete registration details including registrant information, province location (Guangdong), intended use, and regulatory compliance data from the official China NMPA medical device database. Pure Global AI offers free access to China's complete medical device registry, helping global MedTech companies navigate NMPA regulations efficiently.
It is used for the quantitative detection of squamous epithelial cell carcinoma (SCC) antigen in human serum and plasma in vitro, and is mainly used for the treatment and monitoring of cervical cancer in clinical practice.
用于体外定量检测人血清、血浆中鳞状上皮细胞癌（SCC）抗原，临床上主要用于宫颈癌的治疗监测。
It is composed of magnetic particles (M), conjugates (R1), calibrators (optional), and quality controls (optional). Magnetic particles (M): PBS buffer solution containing SCC antigen murine monoclonal antibody coated with magnetic particles, surfactant Tween-20 and preservative Proclin300; Conjugate (R1): PBS buffer solution containing acridine ester-labeled SCC antigen murine monoclonal antibody conjugate and preservative Proclin300; Calibrator 1: lyophilized product containing SCC antigen recombinant protein and TRIS buffer system; Calibrator 2: lyophilized product containing SCC antigen recombinant protein and TRIS buffer system; Quality control level 1: lyophilized product containing SCC antigen recombinant protein and TRIS buffer system; Control Level 2: Lyophilized with SCC antigen recombinant protein and TRIS buffer system.
由磁微粒（M）、结合物（R1）、校准品(选配)、质控品(选配)组成，其中， 磁微粒（M）：含SCC抗原鼠单抗包被的磁微粒及表面活性剂Tween-20、防腐剂Proclin300的PBS缓冲溶液； 结合物（R1）：含吖啶酯标记的SCC抗原鼠单抗结合物及防腐剂 Proclin300的PBS缓冲溶液； 校准品1：含SCC抗原重组蛋白、TRIS缓冲体系的冻干品； 校准品2：含SCC抗原重组蛋白、TRIS缓冲体系的冻干品； 质控品 水平1：含SCC抗原重组蛋白、TRIS缓冲体系的冻干品； 质控品 水平2：含SCC抗原重组蛋白、TRIS缓冲体系的冻干品。
The reagent is stored at 2-8 °C sealed and protected from light, and the shelf life is 12 months. When the reagent tray of the instrument is in a normal refrigeration state (2-8°C), the reagent can be stored in the machine for 28 days after opening the bottle. The calibrators and quality controls should be stored in a closed manner at 2-8°C for 12 months, and should be reconstituted with 0.5mL purified water before use, and can be stored at 2-8°C for 7 days after opening the bottle after reconstitution, and can be stored at -20°C for 28 days, and can only be frozen and thawed once.
试剂于2-8℃密封避光保存，禁止冷冻，保质期为12个月。仪器试剂盘制冷状态正常时（2-8℃），试剂开瓶后在机可保存28天。校准品和质控品2-8℃密闭保存，严禁冷冻，有效期12个月；使用前需用0.5mL纯化水复溶，开瓶复溶后在2-8℃可保存7天；-20℃保存，可稳定28天，仅可冻融1次。