Testosterone (T) Test Reagent Kit (Magnetic Microparticle Chemiluminescence Method) - NMPA Registration 鲁械注准20242400910
Access comprehensive regulatory information for Testosterone (T) Test Reagent Kit (Magnetic Microparticle 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 鲁械注准20242400910 and owned by Shandong Zhushi Pharmaceutical Group Co., Ltd.. The device was approved on October 11, 2024.
This page provides complete registration details including registrant information, province location (Shandong), 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 testosterone (T) content in human serum in vitro.
用于体外定量检测人血清中睾酮（T）的含量。
The reagent is composed of magnetic particle reagent (Ra reagent), acridine ester reagent (Rb reagent), calibrator C0, calibrator C1, calibrator C2, quality control L, quality control H, and main curve card. Magnetic particle reagent (Ra reagent): Magnetic beads coated with testosterone antibody, TRIS buffer, proclin300. Acridine ester reagent (Rb reagent): acridine ester labeled testosterone derivative, TRIS buffer, proclin300. Calibrator C0, Calibrator C1, Calibrator C2: TRIS buffer containing recombinant testosterone and BSA, the assignment of calibrator is batch-specific, and the specific assignment is shown on the bottle label. Control L, Control H: TRIS buffer containing recombinant testosterone, see bottle label for quality control range, batch specific. Main curve card: contains no less than 5 concentration gradient calibration points and corresponding luminescence values (RLU), which are used to fit and generate the main curve after entry.
试剂由磁微粒试剂（Ra试剂）、吖啶酯试剂（Rb试剂）、校准品C0、校准品C1、校准品C2、质控品L、质控品H、主曲线卡组成。 磁微粒试剂（Ra试剂）：包被有睾酮抗体的磁珠、TRIS缓冲液、proclin300。 吖啶酯试剂（Rb试剂）：吖啶酯标记的睾酮衍生物、TRIS缓冲液、proclin300。 校准品C0、校准品C1、校准品C2：内含重组睾酮以及BSA的TRIS缓冲液，校准品的赋值为批特异，具体赋值见瓶身标签。 质控品L、质控品H：内含重组睾酮的TRIS缓冲液，质控范围参见瓶身标签，为批特异。 主曲线卡：含不低于5个浓度梯度校准点及对应发光值（RLU），录入后用于拟合生成主曲线。
Store at 2~8°C in the dark for 12 months
2~8℃避光贮存12个月