Androstenedione (ASD) Test Kit (Magnetic Particulate Chemiluminescence)
- Device class
- Class II
- Model specifications
- 25 tests/box, 50 tests/box, 100 tests/box, 150 tests/box, 200 tests/box, 500 tests/box25测试/盒、50测试/盒、100测试/盒、150测试/盒、200测试/盒、500测试/盒
- Approval department
- Hunan Provincial Drug Administration湖南省药品监督管理局
- Registration number
- 湘械注准20232401016
- Approval date
- October 24, 2023
- Expiry date
- October 23, 2028
- Name
- Hunan XieGuang Biotechnology Co., Ltd.湖南携光生物技术有限公司
- Province/Region
- Hunan湖南
- Address
- The 2nd floor of the 2nd building of the medical device industrial park of the high-tech industrial development zone of Jinshi City, Hunan Province湖南省津市市高新技术产业开发区医疗器械产业园第2栋第2层
- Production address
- 湖南省津市市高新技术产业开发区医疗器械产业园第2栋第1层，第2层
It is used for in vitro quantitative detection of androstenedione (ASD) concentration in human serum and plasma samples, and is mainly used clinically to assist in the diagnosis of hereditary adrenal hyperplasia, adrenal insufficiency and other diseases.
用于体外定量检测人血清、血浆样本中雄烯二酮(ASD)的浓度，临床上主要用于辅助诊断遗传性肾上腺皮质增生、肾上腺皮质功能减退等疾病。
The product consists of R1, M, R2, calibrators, and quality controls. R1: buffer; M: 0.2 mg/mL magnetic particles conjugated to ASD antibody dissolved in buffer; R2: 0.5 μg/mL ASD antibody labeled with alkaline phosphatase in buffer; Calibrator: Chemically synthesized ASD dissolved in buffer; Control: Chemically synthesized ASD dissolved in buffer.
产品由R1、M、R2、校准品、质控品组成。R1:缓冲液;M:0.2mg/mL 已偶联ASD抗体的磁微粒溶于缓冲液中;R2:0.5µg/mL 已标记碱性磷酸酶的ASD抗体溶于缓冲液中;校准品:化学合成的ASD溶于缓冲液中;质控品:化学合成的ASD溶于缓冲液中。
The unopened kit is stored in a closed and dark manner at 2 °C ~ 8 °C for 15 months, and it can be stable for 56 days after opening the bottle at 2 °C ~ 8 °C in the dark. Transportation and storage should be carried out under low temperature conditions of 2 °C ~ 8 °C.
未开瓶试剂盒于2℃～8℃密闭避光保存有效期为15个月，开瓶后2℃～8℃避光保存可稳定56天。运输和保存均应在2℃～8℃低温条件下进行。
- Appendix
- 产品技术要求、说明书
Access comprehensive regulatory information for Androstenedione (ASD) Test Kit (Magnetic Particulate Chemiluminescence) in the China medical device market through Pure Global AI's free database. This Class II medical device is registered under NMPA registration number 湘械注准20232401016 and owned by Hunan XieGuang Biotechnology Co., Ltd.. The device was approved on October 24, 2023.
This page provides complete registration details including registrant information, province location (Hunan), 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.