L-lactate assay kit (lactate oxidase method)
- Device class
- Class II
- Model specifications
- Reagent: 70mL×2 Reagent: 60mL×1 Reagent: 50mL×2 Reagent: 60mL×2 Reagent: 40mL×2 600 test/cassette (Reagent: 44mL×2) 600 test/cassette (Reagent: 40mL×2) 400 test/cassette (Reagent: 40mL×1) 1×150 test/cassette (Reagent: 38mL×1) 500 test/cassette (Reagent: 40mL×2) Calibrator: 1mL×1 (optional) Control: 1mL×2 (optional)试剂:70mL×2 试剂:60mL×1 试剂:50mL×2 试剂:60mL×2 试剂:40mL×2 600 测试/盒(试剂:44mL×2) 600 测试/盒(试剂: 40mL×2) 400 测试/盒(试剂:40mL×1) 1×150测试/盒(试剂:38mL×1) 500 测试/盒(试剂:40mL×2) 校准品:1mL×1(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20212400377
- Approval date
- November 18, 2021
- Expiry date
- November 17, 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 L-lactate (LAC) content in human serum in vitro.
适用于体外定量测定人血清中L-乳酸盐(LAC)的含量。
R Tris buffer 100 mmol/L 4-AMinoantipyrine 0.4 mmol/L TOOS 2.1 mmol/L Peroxidase 1KUl/L Lactate oxidase 600 U/L Preservatives in moderation The calibrator is (optional) composed of 0.9% normal saline and L-lactate The control low value (optional) and the high control value (optional) are composed of 0.9% normal saline and L-lactate
R Tris 缓冲液 100mmol/L 4-氨基安替比林 0.4 mmol/L TOOS 2.1 mmol/L 过氧化物酶 1KUl/L 乳酸氧化酶 600U/L 防腐剂 适量 校准品为(选配)由0.9%生理盐水、L-乳酸盐组成 质控品低值(选配)、质控品高值(选配)由0.9%生理盐水、L-乳酸盐组成
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 opening the bottle of calibrators and quality control products, 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、质控品开瓶后在2℃~8℃避光保存,稳定7天。
Access comprehensive regulatory information for L-lactate assay kit (lactate oxidase 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20212400377 and owned by Anhui Century Kangda Biotechnology Co., Ltd.. The device was approved on November 18, 2021.
This page provides complete registration details including registrant information, province location (Anhui), intended use, and regulatory compliance data from the official China NMPA medical device database. Pure Global AI offers free access to China's complete medical device registry, helping global MedTech companies navigate NMPA regulations efficiently.