Pure Global

Gastric pepsinogen Ⅱ (PGⅡ) detection reagent kit (magnetic particle chemiluminescence method) - NMPA Registration 鲁械注准20242401083

Access comprehensive regulatory information for Gastric pepsinogen Ⅱ (PGⅡ) detection reagent kit (magnetic particle chemiluminescence 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 鲁械注准20242401083 and owned by Shandong Zhushi Pharmaceutical Group Co., Ltd.. The device was approved on January 09, 2025.

This page provides complete registration details including registrant information, province location (Shandong), 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.

Free Database
Powered by Pure Global AI
NMPA Official Data
Class II
鲁械注准20242401083
Gastric pepsinogen Ⅱ (PGⅡ) detection reagent kit (magnetic particle chemiluminescence method)
胃蛋白酶原Ⅱ(PGⅡ)测定试剂盒(磁微粒化学发光法)
NMPA Registration Number: 鲁械注准20242401083
Pure Global
DJ Fang

DJ Fang

MedTech Regulatory Expert

Need help with 30+ markets registration?

Pricing
Intended Use
English

用于体外定量检测人血清样本中胃蛋白酶原Ⅱ的含量.

中文

用于体外定量检测人血清样本中胃蛋白酶原Ⅱ的含量。

Device Classification
Device Class
Class II
Model Specifications
25人份/盒、50人份/盒、100人份/盒、200人份/盒主曲线卡:一张校准品:校准品C0:1×0.5mL(选配)、校准品C1:1×0.5mL(选配)、校准品C2:1×0.5mL(选配)质控品:质控品L:1×0.5mL(选配)、质控品H:1×0.5mL(选配)
25人份/盒、50人份/盒、100人份/盒、200人份/盒主曲线卡:一张校准品:校准品C0:1×0.5mL(选配)、校准品C1:1×0.5mL(选配)、校准品C2:1×0.5mL(选配)质控品:质控品L:1×0.5mL(选配)、质控品H:1×0.5mL(选配)
Approval Department
Shandong Provincial Drug Administration
山东省药品监督管理局
Registration Information
Registration Number
鲁械注准20242401083
Approval Date
January 09, 2025
Expiry Date
December 10, 2029
Registrant
Name
Shandong Zhushi Pharmaceutical Group Co., Ltd.
山东朱氏药业集团有限公司
Province/Region
Shandong
山东
Address
South of Fanlou Road, Shanxian Development Zone
单县开发区樊楼路南
Production Facility
Production Address
山东单县经济技术开发区食品药品产业园单德路6号
Storage Conditions and Expiration
English

试剂在2~8℃避光贮存,有效期12个月,不可冰冻.试剂开瓶后2~8℃不超过30天.校准品开封后,2~8℃不超过30天.质控品开封后,2~8℃不超过7天.

中文

试剂在2~8℃避光贮存,有效期12个月,不可冰冻。试剂开瓶后2~8℃不超过30天。校准品开封后,2~8℃不超过30天。质控品开封后,2~8℃不超过7天。

Additional Information
Changes
生产地址由“山东单县经济技术开发区”变更为“山东单县经济技术开发区食品药品产业园单德路6号”
Appendix
产品技术要求、说明书