Lactate dehydrogenase isoenzyme 1 assay kit (chemical inhibition method) - NMPA Registration 京械注准20232400573
Access comprehensive regulatory information for Lactate dehydrogenase isoenzyme 1 assay kit (chemical inhibition 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20232400573 and owned by Beijing WantaiDerui Diagnostic Technology Co., Ltd.. The device was approved on September 19, 2023.
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For the in vitro quantitative determination of lactate dehydrogenase isoenzyme 1 (LDH1) activity in human serum.
用于体外定量测定人血清中乳酸脱氢酶同工酶1（LDH1）的活性。
Reagent 1: Tris-HCl buffer (pH 9.2) 100 mmol/L L-Lithium lactate 41mmol/L Reagent 2: L-tartaric acid (pH 5.0) 50mmol/L Oxidized coenzyme I..3 combined with water 15mmol/L Calibrators: lyophilized powder, Tris buffer, human serum (content ge; 5%), lactate dehydrogenase isoenzyme 1, target concentration range: 40.0U/L~50.0U/L. Quality controls: lyophilized powder, Tris buffer, human serum (content ge; 5%)), lactate dehydrogenase isoenzyme 1, the target value range of quality control is 1: 30.0U/L~40.0U/L, and level 2: 60.0U/L~80.0U/L. The calibrator and quality control product are batch specific, and the specific concentration is shown on the bottle label.
试剂1：Tris-HCl缓冲液（pH9.2） 100mmol/L L-乳酸锂 41mmol/L 试剂2：L-酒石酸（pH5.0） 50mmol/L 氧化型辅酶Ⅰ.3合水15mmol/L 校准品：冻干粉，Tris缓冲液、人血清（含量ge;5%）、乳酸脱氢酶同工酶1，目标浓度范围：40.0U/L～50.0U/L。 质控品：冻干粉，Tris缓冲液、人血清（含量ge;5%）、乳酸脱氢酶同工酶1，质控品靶值范围：水平1：30.0U/L～40.0U/L；水平2：60.0U/L～80.0U/L。 校准品、质控品批特异，具体浓度见瓶签。
Store at 2°C~8°C, and the expiration date is 12
2℃～8℃保存，有效期为12