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Protein C Assay Kit (Immunoturbidimetric Method) - NMPA Registration 京械注准20242400453

Access comprehensive regulatory information for Protein C Assay Kit (Immunoturbidimetric 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20242400453 and owned by Beijing WantaiDerui Diagnostic Technology Co., Ltd.. The device was approved on August 27, 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20242400453
Protein C Assay Kit (Immunoturbidimetric Method)
触珠蛋白测定试剂盒（免疫比浊法）
NMPA Registration Number: 京械注准20242400453
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Intended Use
English

It is used for the quantitative determination of haptoglobin (HPT) content in human serum in vitro.

中文

用于体外定量测定人血清中触珠蛋白（HPT）的含量。

Device Classification
Device Class
Class II
Model Specifications
Reagent 1: 45mL; 1. Reagent 2: 15mL; 1. Reagent 1: 45mL; 3. Reagent 2: 15mL; 3. Reagent 1: 15mL; 1. Reagent 2: 5mL; 1;1000 tests/box; 500 tests/box; 840 tests/box; 600 tests/box; Calibrator (optional): 0.5mL; 6 (6 levels); Control Level 1 (optional): 0.5mL; 1. Quality control level 2 (optional): 0.5mL; 1.
试剂1：45mL;1、试剂2：15mL;1；试剂1：45mL;3、试剂2：15mL;3；试剂1：15mL;1、试剂2：5mL;1；1000测试/盒；500测试/盒；840测试/盒；600测试/盒；校准品（选配）：0.5mL;6（6水平）；质控品水平1（选配）：0.5mL;1；质控品水平2（选配）：0.5mL;1。
Approval Department
Beijing Municipal Drug Administration
北京市药品监督管理局
Registration Information
Registration Number
京械注准20242400453
Approval Date
August 27, 2024
Expiry Date
August 26, 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(pH7.4),50mmol/L;试剂2:Tris缓冲液(pH7.4),50mmol/L;触珠蛋白抗体,适量. 校准品:Tris缓冲液(pH7.4)、人血清(含量ge; 5%)、触珠蛋白抗原,水平1~水平5目标浓度范围分别为:0.0g/L;0.2g/L～0.3g/L;0.4g/L～0.6g/L;0.8g/L～1.2g/L;1.6g/L～2.4g/L;3.2g/L～4.8g/L. 质控品:Tris缓冲液(pH7.4)、人血清(含量ge; 5%)、触珠蛋白抗原,质控品靶值范围:水平1:0.5g/L～1.5g/L;水平2:1.5g/L～3.5g/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（pH7.4），50mmol/L；试剂2：Tris缓冲液（pH7.4），50mmol/L；触珠蛋白抗体，适量。校准品：Tris缓冲液（pH7.4）、人血清（含量ge;5%）、触珠蛋白抗原，水平1~水平5目标浓度范围分别为：0.0g/L；0.2g/L～0.3g/L；0.4g/L～0.6g/L；0.8g/L～1.2g/L；1.6g/L～2.4g/L；3.2g/L～4.8g/L。质控品：Tris缓冲液（pH7.4）、人血清（含量ge;5%）、触珠蛋白抗原，质控品靶值范围：水平1：0.5g/L～1.5g/L；水平2：1.5g/L～3.5g/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。