D-dimer detection reagent kit (latex-enhanced immunoturbidimetric method) - NMPA Registration 皖械注准20212400371
Access comprehensive regulatory information for D-dimer detection reagent kit (latex-enhanced 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20212400371 and owned by Anhui Century Kangda Biotechnology Co., Ltd.. The device was approved on November 08, 2021.
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It is suitable for the quantitative determination of D-dimer content in human plasma in vitro.
适用于体外定量测定人血浆中D-二聚体的含量。
R1 PBS buffer 0.1mol/L Preservatives in moderation Surfactant in moderation R2 D-dimer antibody sensitized latex particles 0.2 g/l PBS buffer 0.1mol/L Preservatives in moderation Stabilizer to taste Surfactant in moderation Calibrator (lyophilized powder) (optional) Bovine serum albumin, PBS buffer Quality control (lyophilized powder) (optional) bovine serum albumin, PBS buffer
R1 PBS缓冲液 0.1mol/L 防腐剂 适量 表面活性剂 适量 R2 D-二聚体抗体致敏胶乳颗粒 0.2g/l PBS缓冲液 0.1mol/L 防腐剂 适量 稳定剂 适量 表面活性剂 适量 校准品(冻干粉)（选配） 牛血清白蛋白、PBS缓冲液 质控品(冻干粉)（选配）牛血清白蛋白、PBS缓冲液
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 in the dark, and the validity period is 12 months. After reconstitution, the calibrators and quality control products are sealed and protected from light at 2 °C ~ 8 °C and stable for 5 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。 复溶后的校准品、质控品2℃～8℃密封避光保存，稳定5天。