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Apolipoprotein C2 Determination Reagent Kit (Immunoturbidimetric Method) - NMPA Registration 皖械注准20222400073

Access comprehensive regulatory information for Apolipoprotein C2 Determination Reagent 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 皖械注准20222400073 and owned by Anhui Century Kangda Biotechnology Co., Ltd.. The device was approved on March 18, 2022.

This page provides complete registration details including registrant information, province location (Anhui), 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
皖械注准20222400073
Apolipoprotein C2 Determination Reagent Kit (Immunoturbidimetric Method)
载脂蛋白C2测定试剂盒(免疫比浊法)
NMPA Registration Number: 皖械注准20222400073
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Intended Use
English

For the in vitro quantitative determination of apolipoprotein C2 content in human serum.

中文

用于体外定量测定人血清中载脂蛋白 C2 的含量。

Device Classification
Device Class
Class II
Model Specifications
Reagent 1: 45mL×1, Reagent 2: 15mL×1, Reagent 1: 60mL×1, Reagent 2: 20mL×1, Reagent 1: 60mL×4, Reagent 2: 20mL×4, Reagent 1: 60mL×2, Reagent 2: 20mL×2, Reagent 1: 45mL×4, Reagent 2: 15mL×4, Calibratorant: 1mL×1 (optional); Control: 1mL×2 (optional).
试剂 1:45mL×1,试剂 2:15mL×1;试剂 1:60mL×1,试剂 2:20mL×1;试剂 1:60mL×4,试剂 2:20mL×4;试剂 1:60mL×2,试剂 2:20mL×2;试剂 1:45mL×4,试剂 2:15mL×4;校准品:1mL×1(选配);质控品:1mL×2(选配)。
Approval Department
Anhui Provincial Drug Administration
安徽省药品监督管理局
Registration Information
Registration Number
皖械注准20222400073
Approval Date
March 18, 2022
Expiry Date
March 17, 2027
Registrant
Name
Anhui Century Kangda Biotechnology Co., Ltd.
安徽世纪康大生物科技有限公司
Province/Region
Anhui
安徽
Address
Room 401, 5# Electronic Workshop, Science and Technology Innovation Center, No. 82 Huashan Road, Yingzhou Development Zone, Yingzhou District, Fuyang City
阜阳市颍州区颍州开发区华山路82号科创中心5#电子厂房401室
Production Facility
Production Address
阜阳市颍州区颍州开发区华山路82号科创中心5#电子厂房401室
Structure and Composition
English

R1: Tris buffer 10 mmol/L, sodium chloride (NaCl) 0.15mol/L, polyethylene glycol 600 5%; R2: Tris buffer 10 mmol/L, sheep anti-human apolipoprotein C2 antibody 50%; The calibrator is lyophilized powder (optional) consisting of bovine serum albumin and apolipoprotein C2. The low value of the control (optional) and the high value of the control (optional) are lyophilized powder, which is composed of bovine serum albumin and apolipoprotein C2.

中文

R1:Tris 缓冲液 10 mmol/L,氯化钠(NaCl) 0.15mol/L,聚乙二醇 600 5%;R2:Tris 缓冲液 10 mmol/L,羊抗人载脂蛋白 C2 抗体 50%;校准品为冻干粉(选配)由牛血清白蛋白、载脂蛋白 C2 组成。质控品低值(选配)、质控品高值(选配)为冻干粉由牛血清白蛋白、载脂蛋白 C2 组成。

Storage Conditions and Expiration
English

Unopened reagents should be stored at 2 °C ~ 8 °C in the dark, and the validity period is 12 months; The opened reagent was stored at 2 °C ~ 8 °C in the dark and stable for 28 days; Unopened calibrators and quality control products are sealed and protected from light at 2 °C ~ 8 °C, and the validity period is 12 months; After reconstitution of calibrators and quality control products, they are stored at 2 °C ~ 8 °C in the dark and stable for 5 days.

中文

未开启的试剂应在2℃~8℃避光保存,有效期为12个月;开启的试剂在2℃~8℃避光保存,稳定28天;未开启的校准品、质控品在2℃~8℃密封避光保存,有效期为12个月; 校准品、质控品复溶后在2℃~8℃避光保存,稳定5天。