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Pulposoperoxidase assay kit (latex immunoturbidimetry) - NMPA Registration 川械注准20232400261

Access comprehensive regulatory information for Pulposoperoxidase assay kit (latex immunoturbidimetry) in the China medical device market through Pure Global AI's free database. This Class II medical device is registered under NMPA registration number 川械注准20232400261 and owned by Sichuan Xincheng Biological Co., Ltd.. The device was approved on August 17, 2023.

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

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Class II
川械注准20232400261
Pulposoperoxidase assay kit (latex immunoturbidimetry)
髓过氧化物酶测定试剂盒(胶乳免疫比浊法)
NMPA Registration Number: 川械注准20232400261
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Intended Use
English

In vitro quantitative determination of myeloperoxidase concentration in human serum and human plasma samples.

中文

体外定量测定人血清、人血浆样本中髓过氧化物酶的浓度。

Device Classification
Device Class
Class II
Model Specifications
See attached page I
见附页一
Approval Department
Sichuan Provincial Drug Administration
四川省药品监督管理局
Registration Information
Registration Number
川械注准20232400261
Approval Date
August 17, 2023
Expiry Date
August 16, 2028
Registrant
Name
Sichuan Xincheng Biological Co., Ltd.
四川新健康成生物股份有限公司
Province/Region
Sichuan
四川
Address
No. 101, Tianxin Road, Chengdu High-tech Zone
成都市高新区天欣路101号
Production Facility
Production Address
成都市高新区天欣路101号2栋(不包含1楼1-6和1-9)和3栋1楼
Structure and Composition
English

See attached page II

中文

见附页二

Storage Conditions and Expiration
English

The reagent is stored in 2 °C ~ 8 °C closed and protected from light for 18 months, and the storage at 2 °C ~ 8 °C can be stable for 14 days after opening. After the reconstitution of calibrators and quality control products, they can be stable for 2 days when stored at 2 °C ~ 8 °C in the dark, and can be stable for one week at -20 °C, and cannot be repeatedly frozen and thawed.

中文

试剂2℃~8℃密闭避光贮存有效期为18个月,开瓶后2℃~8℃避光贮存可稳定14天。校准品、质控品复溶后2℃~8℃避光贮存可稳定2天,-20℃保存可稳定一周,不可反复冻融。

Additional Information
Appendix
产品技术要求、说明书