EB病毒BNLF2b抗体检测试剂盒(磁微粒化学发光法)
- Device class
- Class III
- Model specifications
- 100人份/盒、100人份/盒(含校准品)、300人份/盒、300人份/盒(含校准品)、500人份/盒、500人份/盒(含校准品)100人份/盒、100人份/盒（含校准品）、300人份/盒、300人份/盒（含校准品）、500人份/盒、500人份/盒（含校准品）
- Approval department
- State Drug Administration国家药品监督管理局
- Registration number
- 国械注准20243402134
- Approval date
- October 24, 2024
- Expiry date
- October 23, 2029
- Name
- Xiamen Innodx BIOTECH Co., Ltd.厦门万泰凯瑞生物技术有限公司
- Province/Region
- Fujian福建
- Address
- 2nd floor, No. 124, Xinyuan Road, Xinyang Street, Haicang District, Xiamen厦门市海沧区新阳街道新园路124号2楼
- Production address
- 厦门市海沧区新阳街道新园路120号6层4单元、126号（1楼、4楼A区）、130号4号楼（A区、B区）和5号楼
本产品用于体外定性检测人血清和血浆样本中EB病毒BNLF2b抗体.本产品可为EB相关的鼻咽癌诊断提供辅助参考信息.
本产品用于体外定性检测人血清和血浆样本中EB病毒BNLF2b抗体。本产品可为EB相关的鼻咽癌诊断提供辅助参考信息。
试剂1、试剂2、校准品1、校准品2.(具体内容详见产品说明书)
试剂1、试剂2、校准品1、校准品2。（具体内容详见产品说明书）
Store at 2~8°C, valid for 12 months.
2～8℃保存，有效期12个月。
- Changes
- 2024-11-01 生产地址由:厦门市海沧区新阳街道新园路124号4楼A区、130号4号楼（A区、B区）和5号楼; 生产地址变更为:厦门市海沧区新阳街道新园路120号6层4单元、126号（1楼、4楼A区）、130号4号楼（A区、B区）和5号楼
- Appendix
- 产品技术要求、说明书
Access comprehensive regulatory information for EB病毒BNLF2b抗体检测试剂盒(磁微粒化学发光法) in the China medical device market through Pure Global AI's free database. This Class III medical device is registered under NMPA registration number 国械注准20243402134 and owned by Xiamen Innodx BIOTECH Co., Ltd.. The device was approved on October 24, 2024.
This page provides complete registration details including registrant information, province location (Fujian), 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.