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Phospholipid assay kit (choline oxidase method) - NMPA Registration 京械注准20242400533

Access comprehensive regulatory information for Phospholipid assay kit (choline oxidase 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 京械注准20242400533 and owned by Beijing WantaiDerui Diagnostic Technology Co., Ltd.. The device was approved on October 10, 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20242400533
Phospholipid assay kit (choline oxidase method)
磷脂测定试剂盒（胆碱氧化酶法）
NMPA Registration Number: 京械注准20242400533
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Intended Use
English

It is used for in vitro quantitative determination of phospholipid (PL) content in human serum.

中文

用于体外定量测定人血清中磷脂（PL）的含量。

Device Classification
Device Class
Class II
Model Specifications
1) Reagent 1: 45mL; 1. Reagent 2: 15mL; 1;2) Reagent 1: 45mL; 3. Reagent 2: 15mL; 3;3) Reagent 1: 15mL; 1. Reagent 2: 5mL; 1;4) 900 test/box (Reagent 1: 71mL; 2. Reagent 2: 26mL; 2) 5) 800 tests/box (reagent 1: 64mL; 2. Reagent 2: 24mL; 2) 6) 400 tests/box (reagent 1: 64mL; 1. Reagent 2: 24mL; 1) 7) 600 tests/box (reagent 1: 52mL; 1. Reagent 2: 19mL; 1) Calibrator: 1.0mL; 1 (optional); Control level 1: 1.0 mL; 1 (optional); Control level 2: 1.0 mL; 1 (optional).
1)试剂1：45mL;1、试剂2：15mL;1；2)试剂1：45mL;3、试剂2：15mL;3；3)试剂1：15mL;1、试剂2：5mL;1；4)900测试/盒（试剂1：71mL;2、试剂2：26mL;2）5)800测试/盒（试剂1：64mL;2、试剂2：24mL;2）6)400测试/盒（试剂1：64mL;1、试剂2：24mL;1）7)600测试/盒（试剂1：52mL;1、试剂2：19mL;1）校准品：1.0mL;1（选配）；质控品水平1：1.0mL;1（选配）；质控品水平2：1.0mL;1（选配）。
Approval Department
Beijing Municipal Drug Administration
北京市药品监督管理局
Registration Information
Registration Number
京械注准20242400533
Approval Date
October 10, 2024
Expiry Date
October 09, 2029
Registrant
Name
Beijing WantaiDerui Diagnostic Technology Co., Ltd.
北京万泰德瑞诊断技术有限公司
Province/Region
Beijing
北京
Address
No. 31 Science Park Road, Changping District, Beijing
北京市昌平区科学园路31号
Production Facility
Production Address
北京市昌平区科学园路31号1号楼1层102和106，1号楼3层A区、B区、C区，7号楼东侧303、西侧401
Structure and Composition
English

试剂1:Tris缓冲液(pH7.85),50mmol/L;磷脂酶,gt; 10KU/L;4-氨基安替比林,3mmoL/L. 试剂2:Tris缓冲液(pH7.85),100mmol/L;胆碱氧化酶,gt; 10KU/L;过氧化物酶,gt; 10KU/L;TOOS,3mmol/L. 校准品:冻干粉,Tris缓冲液(pH7.5plusmn; 0.1)、人血清(含量ge; 5%),磷脂校准品目标浓度范围:2.50mmol/L～3.50mmol/L. 质控品:冻干粉,Tris缓冲液(pH7.5plusmn; 0.1)、人血清(含量ge; 5%),磷脂质控品靶值范围:水平1:1.70mmol/L～2.80mmol/L;水平2:2.80mmol/L～4.60mmol/L. 校准品、质控品批特异,具体浓度见瓶签.

中文

试剂1：Tris缓冲液（pH7.85），50mmol/L；磷脂酶，gt;10KU/L；4-氨基安替比林，3mmoL/L。试剂2：Tris缓冲液（pH7.85），100mmol/L；胆碱氧化酶，gt;10KU/L；过氧化物酶，gt;10KU/L；TOOS，3mmol/L。校准品：冻干粉，Tris缓冲液（pH7.5plusmn;0.1）、人血清（含量ge;5%），磷脂校准品目标浓度范围：2.50mmol/L～3.50mmol/L。质控品：冻干粉，Tris缓冲液（pH7.5plusmn;0.1）、人血清（含量ge;5%），磷脂质控品靶值范围：水平1：1.70mmol/L～2.80mmol/L；水平2：2.80mmol/L～4.60mmol/L。校准品、质控品批特异，具体浓度见瓶签。

Storage Conditions and Expiration
English

2 °C ~ 8 °C storage, valid for 12 months.

中文

2℃～8℃保存，有效期为12个月。