Trans-triiodothyronine assay kit (chemiluminescence method) - NMPA Registration 沪械注准20242400208
Access comprehensive regulatory information for Trans-triiodothyronine assay kit (chemiluminescence method) in the China medical device market through Pure Global AI's free database. This Class II medical device is registered under NMPA registration number 沪械注准20242400208 and owned by Shanghai Kehua Bio-Engineering Co., Ltd.. The device was approved on June 26, 2024.
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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.
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。
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.
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。
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.
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。