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China NMPA legacy archive 沪械注准20242400208

Trans-triiodothyronine assay kit (chemiluminescence method)

反三碘甲状腺原氨酸测定试剂盒(化学发光法)
Shanghai Kehua Bio-Engineering Co., Ltd.Class IINMPAApproved June 26, 2024
Static archiveNMPA · legacy registration snapshot
Device classification
Device class
Class II
Model specifications
See annex.
见附件.
Approval department
Shanghai Municipal Drug Administration
上海市药品监督管理局
Registration information
Registration number
沪械注准20242400208
Approval date
June 26, 2024
Expiry date
June 25, 2029
Registrant
Name
Shanghai Kehua Bio-Engineering Co., Ltd.
上海科华生物工程股份有限公司
Province/Region
Shanghai
上海
Address
1189 Qinzhou North Road, Xuhui District, Shanghai
上海市徐汇区钦州北路1189号
Production facility
Production address
上海市徐汇区桂平路701号
Intended use
English

This kit is used by medical institutions for the quantitative determination of trans-triiodothyronine (rT3) content in human serum samples in vitro for auxiliary diagnosis.

中文

本试剂盒供医疗机构用于体外定量测定人血清样本中的反三碘甲状腺原氨酸(rT3)含量,作辅助诊断用。

Structure and composition
English

Reagent 1 (R1): trans-triiodothyronine antibody-coated magnetic particles, Tris buffer; Reagent 2 (R2): alkaline phosphatase-labeled trans-triiodothyronine antigen, casein hydrolysate, Tris buffer, dissociation agent; Calibration product A, calibration product B: trans-triiodothyronine antigen, dehormonal serum; QC 1, QC 2: trans-triiodothyronine antigen, hormones-dehormine-dehormine. The reagent contains non-reactive ingredient preservatives.

中文

试剂1(R1):反三碘甲状腺原氨酸抗体包被的磁微粒,Tris缓冲液;试剂2(R2):碱性磷酸酶标记的反三碘甲状腺原氨酸抗原,酪蛋白水解物,Tris缓冲液,解离剂;定标品A、定标品B:反三碘甲状腺原氨酸抗原,去激素血清;质控品1、质控品2:反三碘甲状腺原氨酸抗原,去激素血清。试剂中含非反应成分防腐剂。

Storage conditions and expiration
English

Unopened kit, store at 2~8°C, avoid freezing, valid for 12 months. After opening, the kit should be stored at 2~8°C in the instrument, and the validity period is 28 days. The date of manufacture and expiration date are shown on the label of the kit.

中文

未开封试剂盒,2~8℃储存,避免冷冻,有效期12个月。 开封后试剂盒,置于仪器内2~8℃保存,有效期28天。 生产日期、失效日期见试剂盒标签。

About this record

This static archive preserves historical registration fields and translations for Trans-triiodothyronine assay kit (chemiluminescence method), registration 沪械注准20242400208. 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.