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Placental Growth Factor (PLGF) Assay Kit (Magnetic Particle Chemiluminescence Immunoassay) - NMPA Registration 京械注准20242400416

Access comprehensive regulatory information for Placental Growth Factor (PLGF) 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20242400416 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.

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Class II
京械注准20242400416
Placental Growth Factor (PLGF) Assay Kit (Magnetic Particle Chemiluminescence Immunoassay)
胎盘生长因子(PLGF)测定试剂盒 (磁微粒化学发光免疫分析法)
NMPA Registration Number: 京械注准20242400416
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Pricing
Intended Use
English

This product is used for the quantitative determination of placental growth factor (PLGF) content in human serum in vitro.

中文

该产品用于体外定量测定人血清中胎盘生长因子(PLGF)的含量。

Device Classification
Device Class
Class II
Model Specifications
50 servings/box, 100 servings/box, 200 servings/box
50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 Information
Registration Number
京械注准20242400416
Approval Date
August 16, 2024
Expiry Date
August 15, 2029
Registrant
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 Facility
Production Address
北京市房山区城关街道顾八路一区16号1幢
Structure and Composition
English

Note: The target values of calibrators and quality controls are batch specific, see the label for details.

中文

注:校准品靶值、质控品靶值范围具有批特异性,详见标签。

Storage Conditions and Expiration
English

The kit is stored at 2~8 °C, valid for 12 months, and it is strictly forbidden to freeze and avoid direct sunlight.

中文

试剂盒2~8℃储存,有效期12个月,严禁冷冻,避免阳光直射。