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Lipoprotein-associated phospholipase A2 assay kit (chemiluminescence magnetic particle method) - NMPA Registration 鲁械注准20242400770

Access comprehensive regulatory information for Lipoprotein-associated phospholipase A2 assay kit (chemiluminescence magnetic particle 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20242400770 and owned by Shandong Kanghua Biotechnology Co., Ltd.. The device was approved on July 29, 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.

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NMPA Official Data
Class II
鲁械注准20242400770
Lipoprotein-associated phospholipase A2 assay kit (chemiluminescence magnetic particle method)
脂蛋白相关磷脂酶A2测定试剂盒(磁微粒化学发光法)
NMPA Registration Number: 鲁械注准20242400770
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Intended Use
English

It is used for in vitro quantitative determination of lipoprotein-associated phospholipase A2 content in human serum samples.

中文

用于体外定量测定人血清样本中的脂蛋白相关磷脂酶A2的含量。

Device Classification
Device Class
Class II
Model Specifications
25 servings/box, 50 servings/box, 100 servings/box, 200 servings/box.
25人份/盒、50人份/盒、100人份/盒、200人份/盒。
Approval Department
Shandong Provincial Drug Administration
山东省药品监督管理局
Registration Information
Registration Number
鲁械注准20242400770
Approval Date
July 29, 2024
Expiry Date
July 28, 2029
Registrant
Name
Shandong Kanghua Biotechnology Co., Ltd.
山东康华生物医疗科技股份有限公司
Province/Region
Shandong
山东
Address
No. 699, Yuehe Road, Weifang Economic Development Zone
潍坊经济开发区月河路699号
Production Facility
Production Address
潍坊经济开发区古亭街8877号
Structure and Composition
English

Magnetic microsphere solution (R1): magnetic microspheres coated with lipoprotein-associated phospholipase A2 antibody, Tris buffer containing bovine serum albumin; Tracer conjugate (R2): acridine ester-labeled lipoprotein-associated phospholipase A2 antibody, phosphate buffered saline containing bovine serum albumin; Calibrators (C0, C1, C2): Lipoprotein-associated phospholipase A2 antigen, phosphate buffered saline containing bovine serum albumin and ProClin300 (lot specific, see reagent information card for specific concentrations); Controls (Q1, Q2): Lipoprotein-associated phospholipase A2 antigen, phosphate buffer containing bovine serum albumin and ProClin300 (lot specific, see reagent information card for specific QC ranges).

中文

磁性微球溶液(R1):包被脂蛋白相关磷脂酶A2抗体的磁性微球,含牛血清白蛋白的Tris缓冲液; 示踪物结合物(R2):吖啶酯标记的脂蛋白相关磷脂酶A2抗体,含牛血清白蛋白的磷酸盐缓冲液; 校准品(C0、C1、C2):脂蛋白相关磷脂酶A2抗原、含牛血清白蛋白和ProClin300的磷酸盐缓冲液(批特异性,具体浓度见试剂信息卡); 质控品(Q1、Q2):脂蛋白相关磷脂酶A2抗原、含牛血清白蛋白和ProClin300的磷酸盐缓冲液(批特异性,具体质控范围见试剂信息卡)。

Storage Conditions and Expiration
English

Store at 2~8°C, valid for 18 months.

中文

2~8℃保存,有效期18个月。

Additional Information
Appendix
产品技术要求、说明书