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China NMPA legacy archive 京械注准20222400289

Prostate Acid Phosphatase Determination Reagent Kit (α-naphthyl phosphate method)

前列腺酸性磷酸酶测定试剂盒(α-萘基磷酸盐法)
Biosino BIO-TECHNOLOGY and Science INC.Class IINMPAApproved July 22, 2022
Static archiveNMPA · legacy registration snapshot
Device classification
Device class
Class II
Model specifications
Reagent 1 (R1): 2mLx6, Reagent 2 (R2): 2mLx6, Reagent 3 (R3): 3mLx1.
试剂1(R1):2mLx6,试剂2(R2):2mLx6,试剂3(R3):3mLx1。
Approval department
Beijing Municipal Drug Administration
北京市药品监督管理局
Registration information
Registration number
京械注准20222400289
Approval date
July 22, 2022
Expiry date
December 25, 2027
Registrant
Name
Biosino BIO-TECHNOLOGY and Science INC.
中生北控生物科技股份有限公司
Province/Region
Beijing
北京
Address
No. 27, Chaoqian Road, Science and Technology Park, Changping District, Beijing
北京市昌平区科技园区超前路27号
Production facility
Production address
北京市昌平区科技园区超前路27号
Intended use
English

For in vitro quantitative determination of prostate acid phosphatase (PACP) activity in human serum.

中文

用于体外定量测定人血清中前列腺酸性磷酸酶(PACP)的活性。

Structure and composition
English

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

中文

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

Storage conditions and expiration
English

2 °C ~ 8 °C storage, validity period 12 months.

中文

2℃~8℃贮存,有效期12个月。

Additional information
Appendix
产品技术要求、说明书
About this record

This static archive preserves historical registration fields and translations for Prostate Acid Phosphatase Determination Reagent Kit (α-naphthyl phosphate method), registration 京械注准20222400289. It does not establish current authorization or complete current product details.

The default China search uses the separately verified domestic-registration listing, checked daily. Its published listing fields and scope differ from this older snapshot.