Triglyceride Test Kit (Enzyme Colorimetric Method)
- Device class
- Class II
- Model specifications
- "R1:65mL×4R2:70mL×2 R1:65mL×2 R2:70mL×1 R1:40mL×1R2:20mL×1 R1:100mL×4 R2:100mL×2 R1:80mL×2R2:80mL×1 R1:50mL×4 R2:50mL×2 R1:50mL×2R2:50mL×1 R1:40mL×4 R2:20mL×4 R1:16.8mL×12 R2:8.4mL×12 50 test×1 100 test×1 200 test×1 1L×1 校准品:1 mL(可选购) 质控品:1 mL(可选购) ""R1：65mL×4R2：70mL×2 R1：65mL×2 R2：70mL×1 R1：40mL×1R2：20mL×1 R1：100mL×4 R2：100mL×2 R1：80mL×2R2：80mL×1 R1：50mL×4 R2：50mL×2 R1：50mL×2R2：50mL×1 R1：40mL×4 R2：20mL×4 R1：16.8mL×12 R2：8.4mL×12 50 test×1 100 test×1 200 test×1 1L×1 校准品：1 mL（可选购） 质控品：1 mL（可选购） "
- Approval department
- Yunnan Food and Drug Administration云南省食品药品监督管理局
- Registration number
- 滇械注准20162400092
- Approval date
- September 26, 2021
- Expiry date
- September 25, 2026
- Name
- Yunnan Haoxu Biotechnology Co., Ltd.云南昊戌生物科技有限公司
- Province/Region
- Yunnan云南
- Address
- Production workshop on the 3rd floor of No. 4 Industrial Standard Workshop of Block A6-2, High-tech Industrial Base, Majinpu Township, High-tech Industrial Base, Kunming City, Yunnan Province云南省昆明市高新区马金铺乡新城高新技术产业基地A6-2地块4号工业标准厂房3层生产车间
- Production address
- 云南省昆明市高新区马金铺乡新城高新技术产业基地A6-2地块4号工业标准厂房3层生产车间
For in vitro quantitative determination of triglycerides in human serum.
用于人血清中甘油三酯的体外定量测定。
"R1: piperazine-1,4-bis(2-ethanesulfonic acid) buffer (pH 7.0) 0.05mol/L, lipoprotein lipase (LPL) 1000 U/L, N-ethyl-N-(3-propanesulfonyl)-3-methylaniline (ESPMT) 0.375mmol/L, peroxidase (POD) 1000 U/L R2: Glycerol kinase (GK) 500U/L, adenosine triphosphate (ATP) 1.010-3mol/L, glycerophosphate oxidase (GPO) 3000 U/L, 4-aminoantipyrine (4-AAP) 110-3mol/L "
"R1：哌嗪-1,4-双(2-乙磺酸)缓冲液(pH7.0) 0.05mol/L、脂蛋白脂酶（LPL）1000 U/L、N-乙基-N-(3-丙磺基)-3-甲基苯胺（ESPMT）0.375mmol/L、过氧化物酶（POD）1000U/L R2：甘油激酶（GK）500U/L、三磷酸腺苷（ATP）1.010-3mol/L、甘油磷酸氧化酶（GPO）3000 U/L、4-氨基安替比林（4-AAP）110-3mol/L "
"The kit is stored at 2~8 °C, and it can be stable for one year in the dark. After opening the reagent, pay attention to avoid contamination, 2~8 °C can be stable for one week, it is recommended to use it up as soon as possible. "
"试剂盒贮存在2～8℃下，避光保存可稳定一年。 试剂开瓶后注意避免污染，2～8℃可稳定一周，建议尽快用完。 "
Access comprehensive regulatory information for Triglyceride Test Kit (Enzyme Colorimetric 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 滇械注准20162400092 and owned by Yunnan Haoxu Biotechnology Co., Ltd.. The device was approved on September 26, 2021.
This page provides complete registration details including registrant information, province location (Yunnan), 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.