Prostate Acid Phosphatase Determination Reagent Kit (α-naphthyl phosphate method) - NMPA Registration 京械注准20222400289
Access comprehensive regulatory information for Prostate Acid Phosphatase Determination Reagent Kit (α-naphthyl phosphate 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20222400289 and owned by Biosino BIO-TECHNOLOGY and Science INC.. The device was approved on July 22, 2022.
This page provides complete registration details including registrant information, province location (Beijing), 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.
For in vitro quantitative determination of prostate acid phosphatase (PACP) activity in human serum.
用于体外定量测定人血清中前列腺酸性磷酸酶（PACP）的活性。
1. Reagent 1 (R1) (dry powder) alpha;-naphthol phosphate 12.1mmol/L Solid red TR salt 1.2mmol/L Reagent 2 (R2) (liquid) Citric acid buffer 150 mmol/L 1,5-Pentanediamine 220 mmol/L 3. Reagent 3 (R3) (liquid) Acetic acid stabilizer 3mmol/L
1.试剂1（R1）（干粉） alpha;-萘酚磷酸盐 12.1mmol/L 固红TR盐 1.2mmol/L 2.试剂2（R2）（液体） 柠檬酸缓冲液 150 mmol/L 1,5-戊二胺 220 mmol/L 3.试剂3（R3）（液体） 醋酸稳定剂 3mmol/L
2 °C ~ 8 °C storage, validity period 12 months.
2℃～8℃贮存，有效期12个月。