Ferritin Assay Kit (Latex Immunoturbidimetric Method) - NMPA Registration 皖械注准20222400173
Access comprehensive regulatory information for Ferritin Assay Kit (Latex Immunoturbidimetric 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 皖械注准20222400173 and owned by Anhui Century Kangda Biotechnology Co., Ltd.. The device was approved on July 25, 2022.
This page provides complete registration details including registrant information, province location (Anhui), 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 ferritin content in human serum in vitro.
用于体外定量测定人血清中铁蛋白的含量。
R1 Glycine Buffer 0.1mol/L NaCl 5g/LR2 Coated Antiferritin Latex Granules 0.2g/L NaCl 5g/L Glycine Buffer The 0.1mol/L calibrator (optional) consists of HEPES buffer and ferritin. The control low value and the high control value (optional) are composed of HEPES buffer and ferritin.
R1 氨基乙酸缓冲液 0.1mol/L 氯化钠 5g/LR2 包被抗铁蛋白的胶乳颗粒 0.2g/L 氯化钠 5g/L 氨基乙酸缓冲液 0.1mol/L校准品（选配）由HEPES缓冲液、铁蛋白组成。质控品低值、质控品高值（选配）由HEPES缓冲液、铁蛋白组成。
Unopened reagents should be stored at 2°C~8°C in the dark, and the validity period is 12 months; The opened reagent was stored at 2°C~8°C in the dark and stable for 28 days; Unopened calibrators and quality control products are sealed and stored at 2°C~8°C and protected from light, and the validity period is 12 months; After opening, the calibrators and quality control products should be sealed and stored at 2°C~8°C in the dark, and stable for 7 days. Unopened reagents should be stored at 2 °C ~ 8 °C in the dark, and the validity period is 12 months; The opened reagent was stored at 2 °C ~ 8 °C in the dark and stable for 28 days; Unopened calibrators and quality control products are sealed and protected from light at 2 °C ~ 8 °C, and the validity period is 12 months; After opening, the calibrators and quality control products are sealed and protected from light at 2 °C ~ 8 °C, and stable for 7 days.
未开启的试剂应在 2℃～8℃避光保存，有效期为 12 个月；开启的试剂在2℃～8℃避光保存，稳定 28 天；未开启的校准品、质控品在 2℃～8℃密封避光保存，有效期为 12 个月；开启后的校准品、质控品 2℃～8℃密封避光保存，稳定 7 天。未开启的试剂应在2℃～8℃避光保存，有效期为12个月；开启的试剂在2℃～8℃避光保存，稳定28天；未开启的校准品、质控品在2℃～8℃密封避光保存，有效期为12个月；开启后的校准品、质控品2℃～8℃密封避光保存，稳定7天。