Ischemia-modified albumin assay kit (albumin-cobalt binding method)
- Device class
- Class II
- Model specifications
- Reagent 1: 45mL×1Reagent 2: 15mL×1; Reagent 1: 60mL×1 Reagent 2: 20mL×1; Reagent 1: 60mL×4 Reagent 2: 20mL×4; Reagent 1: 60mL×2 Reagent 2: 20mL×2; Reagent 1: 45mL×4 Reagent 2: 15mL×4300 test/cassette (Reagent 1: 57mL×1; Reagent 2: 19mL×1)370 test/cassette (Reagent 1: 69mL×1; Reagent 2: 23mL×1) Calibrator: 1mL×2 (optional) Control: 1mL×2 (optional)试剂 1:45mL×1试剂 2:15mL×1;试剂 1:60mL×1 试剂 2:20mL×1;试剂 1:60mL×4 试剂 2:20mL×4;试剂 1:60mL×2 试剂 2:20mL×2;试剂 1:45mL×4 试剂 2:15mL×4300 测试/盒(试剂 1:57mL×1;试剂 2:19mL×1)370 测试/盒(试剂 1:69mL×1;试剂 2:23mL×1)校准品：1mL×2（选配） 质控品：1mL×2（选配）
- Approval department
- Anhui Provincial Drug Administration安徽省药品监督管理局
- Registration number
- 皖械注准20212400370
- Approval date
- November 08, 2021
- Expiry date
- November 07, 2026
- Name
- Anhui Century Kangda Biotechnology Co., Ltd.安徽世纪康大生物科技有限公司
- Province/Region
- Anhui安徽
- Address
- Room 401, 5# Electronic Workshop, Science and Technology Innovation Center, No. 82 Huashan Road, Yingzhou Development Zone, Yingzhou District, Fuyang City阜阳市颍州区颍州开发区华山路82号科创中心5＃电子厂房401室
- Production address
- 阜阳市颍州区颍州开发区华山路82号科创中心5＃电子厂房401室
It is suitable for the quantitative determination of ischemia-modified albumin content in human serum in vitro.
适用于体外定量测定人血清中缺血修饰白蛋白的含量。
R1 Cobalt chloride 5.0 mmol/L surfactant Appropriate amount of preservative Appropriate amount of R2 Dithiothreitol (DTT) 50 mmol/L preservative An appropriate amount of calibrator (optional) consists of normal saline and ischemia-modified albumin. The control low value (optional) and the high control value (optional) are composed of normal saline and ischemia-modified albumin.
R1 氯化钴 5.0 mmol/L表面活性剂 适量防腐剂 适量R2 二硫苏糖醇（DTT） 50 mmol/L防腐剂 适量校准品（选配）由生理盐水、缺血修饰白蛋白组成。质控品低值（选配）、质控品高值（选配）由生理盐水、缺血修饰白蛋白组成。
Unopened reagents should be stored at 2 °C ~ 8 °C in the dark, and the validity period is 12 months. The opened reagent was stored at 2 °C ~ 8 °C in the dark and stable for 28 days. Unopened calibrators and quality control products are sealed and stored at 2 °C ~ 8 °C in the dark, and the validity period is 12 months. After the calibrator and quality control are opened, they are stored at 2 °C ~ 8 °C in the dark and stable for 7 days.
未开启的试剂应在2℃～8℃避光保存，有效期为12个月。 开启的试剂在2℃～8℃避光保存，稳定28天。 未开启的校准品、质控品在2℃～8℃密封避光保存，有效期为12个月。 校准品、质控品开启后在2℃～8℃避光保存，稳定7天。
Access comprehensive regulatory information for Ischemia-modified albumin assay kit (albumin-cobalt binding 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 皖械注准20212400370 and owned by Anhui Century Kangda Biotechnology Co., Ltd.. The device was approved on November 08, 2021.
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