Gastric pepsinogen Ⅱ (PGⅡ) detection reagent kit (magnetic particle chemiluminescence method)
- 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 number
- 鲁械注准20242401083
- Approval date
- January 09, 2025
- Expiry date
- December 10, 2029
- 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 address
- 山东单县经济技术开发区食品药品产业园单德路6号
用于体外定量检测人血清样本中胃蛋白酶原Ⅱ的含量.
用于体外定量检测人血清样本中胃蛋白酶原Ⅱ的含量。
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.
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。
- 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
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.