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China NMPA legacy archive 浙械注准20242401931

抗甲状腺微粒体抗体检测试剂盒(化学发光微粒子免疫检测法)

抗甲状腺微粒体抗体检测试剂盒（化学发光微粒子免疫检测法）
Medicalsystem Biotechnology Co., Ltd.Class IINMPAApproved October 25, 2024
Static archiveNMPA · legacy registration snapshot
Device classification
Device class
Class II
Model specifications
50 tests/box; 100 tests/box; 200 tests/box; 400 tests/box.
50测试/盒；100测试/盒；200测试/盒；400测试/盒。
Approval department
Zhejiang Provincial Drug Administration
浙江省药品监督管理局
Registration information
Registration number
浙械注准20242401931
Approval date
October 25, 2024
Expiry date
October 24, 2029
Registrant
Name
Medicalsystem Biotechnology Co., Ltd.
美康生物科技股份有限公司
Province/Region
Zhejiang
浙江
Address
No. 299, Qiming South Road, Yinzhou District, Ningbo
宁波市鄞州区启明南路299号
Production facility
Production address
宁波市鄞州区下应街道金达南路1228号
Intended use
English

用于体外定量测定人血清中抗甲状腺微粒体抗体的浓度.

中文

用于体外定量测定人血清中抗甲状腺微粒体抗体的浓度。

Structure and composition
English

标记试剂、固相试剂、校准品1、校准品2、质控品1、质控品2、样本稀释液.(具体内容详见说明书)

中文

标记试剂、固相试剂、校准品1、校准品2、质控品1、质控品2、样本稀释液。（具体内容详见说明书）

Storage conditions and expiration
English

Store at 2~8°C, valid for 12 months.

中文

2～8℃保存，有效期12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 抗甲状腺微粒体抗体检测试剂盒(化学发光微粒子免疫检测法), registration 浙械注准20242401931. 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.