D-dimer detection reagent kit (latex-enhanced immunoturbidimetric method)
- Device class
- Class II
- Model specifications
- Reagent 1: 30mL×1; Reagent 2: 10mL×1 Reagent 1: 30mL×2; Reagent 2: 10 mL×2 Reagent 1: 45mL×1; Reagent 2: 15mL×1 Reagent 1: 45mL×2; Reagent 2: 15 mL×2 Reagent 1: 60mL×1; Reagent 2: 20mL×1 Reagent 1: 60mL×2; Reagent 2: 20 mL×2 Reagent 1: 90mL×1; Reagent 2: 30mL×1 Reagent 1: 90mL×2; Reagent 2: 30mL×2 Calibrators: 1ml×1;0.5ml×1 (optional) Controls: 1ml×2;0.5ml×2 (optional)试剂1:30mL×1; 试剂2:10mL×1 试剂1:30mL×2; 试剂2:10mL×2 试剂1:45mL×1; 试剂2:15mL×1 试剂1:45mL×2; 试剂2:15mL×2 试剂1:60mL×1; 试剂2:20mL×1 试剂1:60mL×2; 试剂2:20mL×2 试剂1:90mL×1; 试剂2:30mL×1 试剂1:90mL×2; 试剂2:30mL×2 校准品：1ml×1；0.5ml×1（选配） 质控品：1ml×2；0.5ml×2（选配）
- Approval department
- Anhui Provincial Drug Administration安徽省药品监督管理局
- Registration number
- 皖械注准20212400371
- Approval date
- November 08, 2021
- Expiry date
- November 07, 2026
- Name
- Anhui Century Kangda Biotechnology Co., Ltd.安徽世纪康大生物科技有限公司
- Province/Region
- Anhui安徽
- Address
- Room 401, 5# Electronic Workshop, Science and Technology Innovation Center, No. 82 Huashan Road, Yingzhou Development Zone, Yingzhou District, Fuyang City阜阳市颍州区颍州开发区华山路82号科创中心5＃电子厂房401室
- Production address
- 阜阳市颍州区颍州开发区华山路82号科创中心5＃电子厂房401室
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。
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.
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.