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B-type Natriuretic Peptide (BNP) Quality Control - NMPA Registration 粤械注准20242401696

Access comprehensive regulatory information for B-type Natriuretic Peptide (BNP) Quality Control in the China medical device market through Pure Global AI's free database. This Class II medical device is registered under NMPA registration number 粤械注准20242401696 and owned by Guangzhou Wondfo BIOTECH Co., Ltd.. The device was approved on December 19, 2024.

This page provides complete registration details including registrant information, province location (Guangdong), 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
粤械注准20242401696
B-type Natriuretic Peptide (BNP) Quality Control
B型钠尿肽(BNP)质控品
NMPA Registration Number: 粤械注准20242401696
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Pricing
Intended Use
English

本产品适用于监控和评价广州万孚生物技术股份有限公司生产的B 型钠尿肽(BNP)测定试剂(干式荧光免疫一步法)检测时的质量控制.

中文

本产品适用于监控和评价广州万孚生物技术股份有限公司生产的B 型钠尿肽(BNP)测定试剂(干式荧光免疫一步法)检测时的质量控制。

Device Classification
Device Class
Class II
Model Specifications
Lyophilized powder type, level 1: 0.5mL×1; level 2: 0.5mL×1; level 3: 0.5mL×1.
冻干粉型,水平1:0.5mL×1;水平2:0.5mL×1;水平3:0.5mL×1。
Approval Department
Guangdong Provincial Drug Administration
广东省药品监督管理局
Registration Information
Registration Number
粤械注准20242401696
Approval Date
December 19, 2024
Expiry Date
December 18, 2029
Registrant
Name
Guangzhou Wondfo BIOTECH Co., Ltd.
广州万孚生物技术股份有限公司
Province/Region
Guangdong
广东
Address
No. 8, Lizhishan Road, Science City, Huangpu District, Guangzhou
广州市黄埔区科学城荔枝山路8号
Production Facility
Production Address
广州市黄埔区科学城荔枝山路8号
Structure and Composition
English

This product is a lyophilized powder, the main component is B-type natriuretic peptide (BNP) antigen.

中文

本产品为冻干粉,主要成分为B型钠尿肽(BNP)抗原。

Storage Conditions and Expiration
English

4℃~30℃密封避光保存,有效期为12个月.开盖复溶后在4℃~30℃可保存8小时,分装后可在-20℃条件下冻存28天,仅可冻融一次,不可反复冻融.

中文

4℃~30℃密封避光保存,有效期为12个月。开盖复溶后在4℃~30℃可保存8小时,分装后可在-20℃条件下冻存28天,仅可冻融一次,不可反复冻融。

Additional Information
Appendix
产品技术要求、说明书