Type IV Collagen Detection Test Kit (Latex Immunoassay) - NMPA Registration 京械注准20232400556
Access comprehensive regulatory information for Type IV Collagen Detection Test Kit (Latex 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 京械注准20232400556 and owned by Beijing SenMeiXiKeMa Biotechnology Co., Ltd.. The device was approved on September 13, 2023.
This page provides complete registration details including registrant information, province location (Beijing), intended use, and regulatory compliance data from the official China NMPA medical device database. Pure Global AI offers free access to China's complete medical device registry, helping global MedTech companies navigate NMPA regulations efficiently.
It is used for the quantitative determination of the content of type IV. collagen in human serum in vitro.
用于体外定量测定人血清中Ⅳ型胶原的含量。
compose concentration Reagent 1 Tris buffer (pH 6.0~9.0) 100mmol/L Polyethylene glycol 6000 30g/L Reagent 2 Tris buffer (pH 6.0~9.0) 100mmol/L Polyethylene glycol 6000 30g/L CIV. Antibody-bound latex particles 0.5% Calibrator Liquid, 4 levels (Optional) Tris buffer (pH 6.0~9.0) 20mmol/L Human serum 300mL/L CIV. Target concentration range Level 1: (80~113) ng/mL Level 2: (170~230)ng/mL Level 3: (350~450)ng/mL Level 4: (700~900) ng/mL Controls Liquid, 2 levels (Optional) Tris buffer (pH 6.0~9.0) 20mmol/L Human serum 300mL/L CIV. Target concentration range Level 1: (90~130) ng/mL Level 2: (140~200) ng/mL The target lot of the calibrator is specific, see the target value list for details. The quality control and quality control range is specific to the batch, see the target value list for details.
组成 浓度 试剂1 Tris缓冲液(pH 6.0～9.0) 100mmol/L 聚乙二醇6000 30g/L 试剂2 Tris缓冲液(pH 6.0～9.0) 100mmol/L 聚乙二醇6000 30g/L CⅣ抗体结合的胶乳颗粒 0.5% 校准品 液体,4水平 （选配） Tris缓冲液(pH 6.0～9.0) 20mmol/L 人血清 300mL/L CⅣ目标浓度范围 水平1：（80～113）ng/mL 水平2：（170～230）ng/mL 水平3：（350～450）ng/mL 水平4：（700～900）ng/mL 质控品 液体,2水平 （选配） Tris缓冲液(pH 6.0～9.0) 20mmol/L 人血清 300mL/L CⅣ目标浓度范围 水平1：（90～130）ng/mL 水平2：（140～200）ng/mL 校准品靶值批特异，详见靶值单。质控品质控范围批特异，详见靶值单。
Store in the dark under the condition of 2 °C ~ 8 °C, there is
2℃～8℃条件下避光保存，有