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China NMPA legacy archive 川械注准20242400286

抗磷脂酶A2受体抗体IgG测定试剂盒(化学发光法)

抗磷脂酶A2受体抗体IgG测定试剂盒（化学发光法）
Sichuan Orienter Biotechnology Co., Ltd.Class IINMPAApproved November 14, 2024
Static archiveNMPA · legacy registration snapshot
Device classification
Device class
Class II
Model specifications
See annex.
见附件。
Approval department
Sichuan Provincial Drug Administration
四川省药品监督管理局
Registration information
Registration number
川械注准20242400286
Approval date
November 14, 2024
Expiry date
November 13, 2029
Registrant
Name
Sichuan Orienter Biotechnology Co., Ltd.
四川沃文特生物技术有限公司
Province/Region
Sichuan
四川
Address
No. 9, Kangqiang 4th Road, Chengdu High-tech Zone
成都高新区康强四路9号
Production facility
Production address
成都高新区康强四路9号W2、W7；成都高新区康强四路9号W2、W7
Intended use
English

本试剂盒用于体外定量测定人血清或血浆样本中抗磷脂酶A2受体抗体IgG(PLA2R IgG)的浓度.

中文

本试剂盒用于体外定量测定人血清或血浆样本中抗磷脂酶A2受体抗体IgG（PLA2R IgG）的浓度。

Structure and composition
English

试剂1(R1):免疫磁珠;试剂2(R2):酶结合物;试剂3(R3):分析缓冲液 ;PLA2R IgG校准品;PLA2R IgG质控品.(具体内容详见产品说明书)

中文

试剂1（R1）：免疫磁珠；试剂2（R2）：酶结合物；试剂3（R3）：分析缓冲液 ；PLA2R IgG校准品；PLA2R IgG质控品。（具体内容详见产品说明书）

Storage conditions and expiration
English

2°C~8°C sealed and protected from light, and the validity period is 15 months.

中文

2℃～8℃密闭避光保存有效期为15个月。

Additional information
Appendix
产品技术要求、说明书
About this record

This static archive preserves historical registration fields and translations for 抗磷脂酶A2受体抗体IgG测定试剂盒(化学发光法), registration 川械注准20242400286. 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.