Trans-triiodothyronine assay kit (chemiluminescence method)
- Device class
- Class II
- Model specifications
- See annex.
- Approval department
- Shanghai Municipal Drug Administration
- Registration number
- 沪械注准20242400208
- Approval date
- June 26, 2024
- Expiry date
- June 25, 2029
- Province/Region
- Shanghai
- Address
- 1189 Qinzhou North Road, Xuhui District, Shanghai
- Production address
- 上海市徐汇区桂平路701号
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。
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