China NMPA legacy archive 粤械注准20242401605D-dimer (D-Dimer) controls
- Device class
- Class II
- Model specifications
- Lyophilized powder type, level 1: 0.5mL×1; level 2: 0.5mL×1; level 3: 0.5mL×1.
- Approval department
- Guangdong Provincial Drug Administration
- Registration number
- 粤械注准20242401605
- Approval date
- December 02, 2024
- Expiry date
- December 01, 2029
- Province/Region
- Guangdong
- Address
- No. 8, Lizhishan Road, Science City, Huangpu District, Guangzhou
- Production address
- 广州市黄埔区科学城荔枝山路8号
本产品适用于广州万孚生物技术股份有限公司生产的 D-二聚体(D-Dimer)测定试剂(干式荧光免疫一步法)及其适用仪器组成的检测系统,用于 D-二聚体(D-Dimer)检测项目的质量控制.
本产品适用于广州万孚生物技术股份有限公司生产的 D-二聚体（D-Dimer）测定试剂（干式荧光免疫一步法）及其适用仪器组成的检测系统，用于 D-二聚体（D-Dimer）检测项目的质量控制。
本产品为冻干粉,主要成分为 D-二聚体(D-Dimer)抗原(人源蛋白)、Tris-HCl 缓冲液、Proclin300.
本产品为冻干粉，主要成分为 D-二聚体（D-Dimer）抗原（人源蛋白）、Tris-HCl 缓冲液、Proclin300。
4℃～30℃密封避光保存,有效期为12个月.开盖复溶后在4℃～30℃可保存8小时,分装后可在-20℃条件下冻存28天,不可反复冻融.
4℃～30℃密封避光保存，有效期为12个月。开盖复溶后在4℃～30℃可保存8小时，分装后可在-20℃条件下冻存28天，不可反复冻融。
- Appendix
- 产品技术要求、说明书
This static archive preserves historical registration fields and translations for D-dimer (D-Dimer) controls, registration 粤械注准20242401605. It does not establish current authorization or complete current product details.
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