Taiwan FDA registration b812709f275b793e0fbd56f90fdfc97c

"DXN" alkaline phosphatase test reagent

TW: “德信”鹼性磷酸酶檢驗試劑
Taiwan flagTaiwan·Risk Class 2·DIASYS DIAGNOSTIC SYSTEMS GMBH·Registered Apr 08, 2020 – Apr 08, 2030Active
Registration details
Analysis ID
b812709f275b793e0fbd56f90fdfc97c
Customs Code
DHA05603346606
Company information
Manufacturer Country
Germany
Authorized Representative
TUNYEN ENTERPRISE CORPORATION
Product details
Intended Use
A diagnostic reagent used in optical colorimetric analysis instruments to quantify alkaline phosphatase (AP) in serum or plasma.
Product Type (Level 1)
A Clinical chemistry and clinical toxicology
Product Type (Level 2)
A.1050 Alkaline phosphatase or isoenzyme testing system
Import Information
import
Dates and status
Registration Date
Apr 08, 2020
Expiry Date
Apr 08, 2030
About this record

Access comprehensive regulatory information for "DXN" alkaline phosphatase test reagent in Taiwan's medical device market through Pure Global AI's free database. This Risk Class 2 medical device is registered under number b812709f275b793e0fbd56f90fdfc97c and manufactured by DIASYS DIAGNOSTIC SYSTEMS GMBH. The authorized representative in Taiwan is TUNYEN ENTERPRISE CORPORATION.

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