Taiwan FDA registration 691a7eb906426eccf213df2e6138dc75

"Siemens" second generation alkaline phosphatase concentrate group

TW: “西門子”第二代鹼性磷酸酶濃縮試劑組

Taiwan·Risk Class 2·SIEMENS HEALTHCARE DIAGNOSTICS INC.;; RANDOX LABORATORIES LTD.·Registered Apr 12, 2016 – Apr 12, 2026Expired

Registration details

Analysis ID: 691a7eb906426eccf213df2e6138dc75
Customs Code: DHA05602832800

Company information

Manufacturer: SIEMENS HEALTHCARE DIAGNOSTICS INC.;; RANDOX LABORATORIES LTD.
Manufacturer Country: United Kingdom;;United States
Authorized Representative: SIEMENS HEALTHCARE LIMITED

Product details

Intended Use: This product is used with an ADVIA Chemistry 1200, 1800, 2400, or XPT analyzer to quantitatively detect alkaline phosphatase in human 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: Contract manufacturing;; input

Dates and status

Registration Date: Apr 12, 2016
Expiry Date: Apr 12, 2026

About this record

Access comprehensive regulatory information for "Siemens" second generation alkaline phosphatase concentrate group in Taiwan's medical device market through Pure Global AI's free database. This Risk Class 2 medical device is registered under number 691a7eb906426eccf213df2e6138dc75 and manufactured by SIEMENS HEALTHCARE DIAGNOSTICS INC.;; RANDOX LABORATORIES LTD.. The authorized representative in Taiwan is SIEMENS HEALTHCARE LIMITED.

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