Aspartate aminotransferase mitochondrial isoenzyme assay kit (immunosuppressive method)
- Device class
- Class II
- Model specifications
- 1) Reagent 1: 48mL; 1. Reagent 2: 12mL; 1; 2) Reagent 1: 48mL; 3. Reagent 2: 12mL; 3; 3) Reagent 1: 20mL; 1. Reagent 2: 5mL; 1; 4) 560 test/box; 5) 1120 test/box; 6) 900 tests/box. Calibrator: 1.0mL; 1 (optional); Control level 1: 1.0 mL; 1 (optional); Control level 2: 1.0 mL; 1 (optional).1)试剂1：48mL;1、试剂2：12mL;1； 2)试剂1：48mL;3、试剂2：12mL;3； 3)试剂1：20mL;1、试剂2：5mL;1； 4)560测试/盒； 5)1120测试/盒； 6)900测试/盒。 校准品：1.0mL;1（选配）； 质控品水平1：1.0mL;1（选配）； 质控品水平2：1.0mL;1（选配）。
- Approval department
- Beijing Municipal Drug Administration北京市药品监督管理局
- Registration number
- 京械注准20232400574
- Approval date
- September 19, 2023
- Expiry date
- September 18, 2028
- Name
- Beijing WantaiDerui Diagnostic Technology Co., Ltd.北京万泰德瑞诊断技术有限公司
- Province/Region
- Beijing北京
- Address
- No. 31 Science Park Road, Changping District, Beijing北京市昌平区科学园路31号
- Production address
- 北京市昌平区科学园路31号1号楼1层102和106，1号楼3层A区、B区、C区，7号楼东侧303、西侧401
For in vitro quantitative determination of aspartate aminotransferase mitochondrial isoenzyme activity in human serum.
用于体外定量测定人血清中天门冬氨酸氨基转移酶线粒体同工酶的活性。
Reagent 1: Tris buffer (pH 7.80) 49.5 mmol/L L-aspartic acid 150mmol/L Malate dehydrogenase (MDH) 600U/L Lactate dehydrogenase (LDH) 4000U/L Sheep anti-human c-AST antibody appropriate amount Reagent 2: Tris buffer (pH 9.73) 50 mmol/L alpha;-ketoglutarate disodium salt 60mmol/L Reduced Coenzyme I Disodium Salt (NADHbull; 2Na)1.58mmol/L Calibrator (lyophilized powder): Tris buffer, human serum (content ge; 5%), aspartate aminotransferase mitochondrial isoenzyme, target concentration range: 50.0U/L~80.0U/L. Quality control (lyophilized powder): Tris buffer, human serum (content ge; 5%), aspartate aminotransferase mitochondrial isoenzyme, the target value range of the quality control substance: level 1: 15.0U/L~30.0U/L, level 2: 35.0U/L~65.0U/L. The calibrator and quality control product are batch specific, and the specific concentration is shown on the bottle label.
试剂1： Tris缓冲液（pH7.80） 49.5mmol/L L-天门冬氨酸 150mmol/L 苹果酸脱氢酶（MDH） 600U/L 乳酸脱氢酶（LDH） 4000U/L 羊抗人c-AST抗体 适量 试剂2： Tris缓冲液（pH9.73） 50mmol/L alpha;-酮戊二酸二钠盐 60mmol/L 还原型辅酶I二钠盐（NADHbull;2Na）1.58mmol/L 校准品（冻干粉）：Tris缓冲液、人血清（含量ge;5%）、天门冬氨酸氨基转移酶线粒体同工酶，目标浓度范围：50.0U/L～80.0U/L。 质控品（冻干粉）：Tris缓冲液、人血清（含量ge;5%）、天门冬氨酸氨基转移酶线粒体同工酶，质控品靶值范围：水平1：15.0U/L～30.0U/L，水平2：35.0U/L～65.0U/L。 校准品、质控品批特异，具体浓度见瓶签。
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- Appendix
- 产品技术要求、说明书
Access comprehensive regulatory information for Aspartate aminotransferase mitochondrial isoenzyme assay kit (immunosuppressive 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 京械注准20232400574 and owned by Beijing WantaiDerui Diagnostic Technology Co., Ltd.. The device was approved on September 19, 2023.
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