Thyroid-stimulating hormone test kit (chemiluminescence immunoassay) - NMPA Registration 湘械注准20222400071
Access comprehensive regulatory information for Thyroid-stimulating hormone test kit (chemiluminescence immunoassay) in the China medical device market through Pure Global AI's free database. This Class II medical device is registered under NMPA registration number 湘械注准20222400071 and owned by Hunan Huaxi Pharmaceutical Co., Ltd.. The device was approved on January 18, 2022.
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It is used for the quantitative detection of thyroid-stimulating hormone (TSH) concentration in human serum in vitro.
用于体外定量检测人血清中促甲状腺素(TSH)的浓度。
Reagent 1: Biotin-labeled thyrotropin-mab (approx. 0.5 mg/L, murine), phosphate buffer (containing 1% bovine serum protein, 0.1% Proclin300, PH7.4); Reagent 2: ACRIDINE-labeled thyrotropin-mab (approx. 0.5 mg/L, murine), phosphate buffer (with 1% bovine serum protein, 0.1% Proclin300, PH7.4); Reagent M: Streptavidin-coated magnetic particles (approx. 0.3 mg/mL), treated with antiseptic; Series calibrators: with thyroid-stimulating hormone (human), phosphate buffer (containing 1% bovine serum protein, 0.1% Proclin300, PH7.4); The concentrations were about 0, 0.1, 0.5, 2.5, 15, and 60 uIU/mL.
试剂 1:含生物素标记的促甲状腺素单抗(约 0.5mg/L,鼠源性),磷酸盐缓冲液(含 1%牛血清蛋白,0.1%Proclin300,PH7.4);试剂 2:含吖啶酯标记的促甲状腺素单抗(约 0.5mg/L,鼠源性),磷酸盐缓冲液(含 1%牛血清蛋白,0.1% Proclin300,PH7.4);试剂 M:含链霉亲和素包被的磁颗粒(约 0.3mg/mL),经防腐处理;系列校准品:含促甲状腺素(人源性),磷酸盐缓冲液(含 1%牛血清蛋白,0.1%Proclin300,PH7.4);浓度分别约为:0、0.1、0.5、2.5、15、60uIU/mL。
Store at 2~8°C with a validity period of 18 months; The opened reagents and calibrators can be stored stably for 60 days at 2~8°C.
2～8℃环境下储存，有效期18个月；开封的试剂及校准品，2～8℃ 环境下可稳定保存60天。