L-lactate assay kit (lactate oxidase method) - NMPA Registration 皖械注准20212400377
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.
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。