China NMPA legacy archive 吉械注准20252400060Angiotensin II assay kit (chemiluminescence immunoassay)
- Device class
- Class II
- Model specifications
- 1×50 test/box; 1×50 test/box (excluding calibrators and quality controls); 2×50 tests/box; 2×50 test/box (excluding calibrators and quality controls); 1×100 tests/box; 1×100 tests/box (excluding calibrators and quality controls); 2×100 tests/box; 2×100 tests/box (excluding calibrators and quality controls); 4×100 tests/box; 4×100 tests/box (excluding calibrators and quality controls); 1×200 tests/box; 1×200 tests/box (excluding calibrators and quality controls); 2×200 tests/box; 2×200 tests/box (excluding calibrators and quality controls).
- Approval department
- Jilin Provincial Drug Administration
- Registration number
- 吉械注准20252400060
- Approval date
- January 21, 2025
- Expiry date
- January 20, 2030
- Province/Region
- Jilin
- Address
- No. 95, Yunhe Street, Changchun High-tech Industrial Development Zone
- Production address
- 长春市高新技术产业开发区云河街95号
用于体外定量检测人血浆中血管紧张素Ⅱ的含量。
试剂R1：链霉亲和素磁颗粒 ≥0.03%，三（羟甲基）氨基甲烷缓冲液 10～100mmol/L，叠氮化钠 ≤0.1%，ProClin 300 ≤0.2%； 试剂R2：吖啶酯标记的血管紧张素Ⅱ鼠单抗 ≥10ng/mL，1,3-二 [三（羟甲基）] 甲氨基丙烷缓冲液 50～400mmol/L，ProClin 300 ≤0.2%； 试剂R3：生物素标记的血管紧张素Ⅱ衍生物 ≥3ng/mL，1,3-二 [三（羟甲基）] 甲氨基丙烷缓冲液 50～400mmol/L，ProClin 300 ≤0.2%； 校准品（高值、低值）：添加血管紧张素Ⅱ的蛋白组分 含量见标签，磷酸盐缓冲液10～100mmol/L，叠氮化钠 ≤0.1%，ProClin 300 ≤0.2%； 质控品（水平1、水平2）：添加血管紧张素Ⅱ的蛋白组分 含量见标签，磷酸盐缓冲液 10～100mmol/L，叠氮化钠 ≤0.1%，ProClin 300 ≤0.2%；
- Appendix
- 产品技术要求
This static archive preserves historical registration fields and translations for Angiotensin II assay kit (chemiluminescence immunoassay), registration 吉械注准20252400060. It does not establish current authorization or complete current product details.
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