China NMPA legacy archive 鲁械注准20242401083Gastric 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）
Shandong Zhushi Pharmaceutical Group Co., Ltd.Class IINMPAApproved January 09, 2025
Static archiveNMPA · legacy registration snapshot
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)
- Approval department
- Shandong Provincial Drug Administration
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）
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
- Province/Region
- Shandong
- Address
- South of Fanlou Road, Shanxian Development Zone
山东
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
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。
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
About this record
This static archive preserves historical registration fields and translations for Gastric pepsinogen Ⅱ (PGⅡ) detection reagent kit (magnetic particle chemiluminescence method), registration 鲁械注准20242401083. It does not establish current authorization or complete current product details.
The default China search uses the separately verified domestic-registration listing, checked daily. Its published listing fields and scope differ from this older snapshot.