D-dimer (D-Dimer) Assay Kit (Chemiluminescence Method) - NMPA Registration 粤械注准20242400424
Access comprehensive regulatory information for D-dimer (D-Dimer) Assay Kit (Chemiluminescence 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 粤械注准20242400424 and owned by Aikang Diagnostics Co., Ltd.. The device was approved on March 26, 2024.
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It is used for in vitro quantitative detection of D-dimer content in human plasma and whole blood, and is mainly used in clinical practice for the auxiliary diagnosis of disseminated intravascular coagulation and the monitoring of thrombolytic therapy.
用于体外定量检测人血浆、全血中D－二聚体（D-Dimer）的含量，临床上主要用于弥散性血管内凝血的辅助诊断以及溶栓治疗的监测。
It is mainly composed of magnetic particles, enzyme markers, calibrator 1, calibrator 2, quality control 1 (optional), and quality control 2 (optional). Magnetic particles (R1): superparamagnetic particles coated with D-dimer antibody suspended in PBS (phosphate) buffer containing 0.05% Proclin300 (preservative); Enzyme Marker (R2):D-Dimeric Antibody-Alkaline Phosphatase Marker diluted in PBS (phosphate) buffer with 0.05% Proclin300 (preservative); Calibrator 1 and Calibrator 2: D-Dimer antigen, PBS (phosphate) buffer with 0.05% ProClin-300 (preservative); Control 1 (optional) and Control 2 (optional) :D-Dimer antigen, PBS (phosphate) buffer with 0.05% ProClin-300 (preservative).
主要由磁微粒、酶标记物、校准品1、校准品2、质控品1（选配）、质控品2（选配）组成。 磁微粒（R1）:包被着D-二聚体抗体的超顺磁性微粒悬浮于PBS（磷酸盐）缓冲液中，含0.05%Proclin300（防腐剂）； 酶标记物(R2):D-二聚体抗体-碱性磷酸酶标记物稀释于PBS（磷酸盐）缓冲液中，含0.05%Proclin300（防腐剂）； 校准品1和校准品2：D-Dimer抗原，PBS（磷酸盐）缓冲液，含0.05%ProClin-300（防腐剂）； 质控品1（选配）和质控品2（选配）：D-Dimer抗原，PBS（磷酸盐）缓冲液，含0.05%ProClin-300（防腐剂）。
When stored in the dark at 2~8°C, the validity period is 18 months. After opening, reagents, calibrators, and quality controls should be stored upright at 2~8°C and protected from light for up to 30 days.
在2～8℃ 环境下避光储存时，有效期为18个月。试剂、校准品、质控品开封后，在2～8℃环境下直立放置、避光储存，最长可储存30天。