Anti-Mullerian Hormone (AMH) Assay Kit (Magnetic Particle Chemiluminescence Immunoassay)
- Device class
- Class II
- Model specifications
- 50 servings/box, 100 servings/box, 200 servings/box50人份/盒、100人份/盒、200人份/盒
- Approval department
- Beijing Municipal Drug Administration北京市药品监督管理局
- Registration number
- 京械注准20242400418
- Approval date
- August 16, 2024
- Expiry date
- August 15, 2029
- Name
- Beijing Tigsun Diagnostics Co., Ltd.北京泰格科信生物科技有限公司
- Province/Region
- Beijing北京
- Address
- Building 1, No. 16, District 1, Guba Road, Chengguan Street, Fangshan District, Beijing北京市房山区城关街道顾八路一区16号1幢
- Production address
- 北京市房山区城关街道顾八路一区16号1幢
This product is used for the quantitative determination of anti-Mullerian hormone (AMH) content in human serum in vitro.
该产品用于体外定量测定人血清中抗缪勒管激素(AMH)的含量。
Note: The target values of calibrators and quality controls are batch specific, see the label for details.
注：校准品靶值、质控品靶值范围具有批特异性，详见标签。
The kit is stored at 2~8 °C, valid for 12 months, and it is strictly forbidden to freeze and avoid direct sunlight.
试剂盒2～8℃储存，有效期12个月，严禁冷冻，避免阳光直射。
Access comprehensive regulatory information for Anti-Mullerian Hormone (AMH) Assay Kit (Magnetic Particle Chemiluminescence Immunoassay) in the China medical device market through Pure Global AI's free database. This Class II medical device is registered under NMPA registration number 京械注准20242400418 and owned by Beijing Tigsun Diagnostics Co., Ltd.. The device was approved on August 16, 2024.
This page provides complete registration details including registrant information, province location (Beijing), 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.