Taiwan FDA registration d8a797f9a5dc08e99d871d53c58b90fc

"Siemens" microalbumin/creatinine tube solution

TW: “西門子” 微量白蛋白/肌氨酸酐品管液

Taiwan·Risk Class 2·SIEMENS HEALTHCARE DIAGNOSTICS INC.;; FISHER DIAGNOSTICS·Registered Mar 08, 2019 – Mar 08, 2029Active

Registration details

Analysis ID: d8a797f9a5dc08e99d871d53c58b90fc
Customs Code: DHA05603220805

Company information

Manufacturer: SIEMENS HEALTHCARE DIAGNOSTICS INC.;; FISHER DIAGNOSTICS
Manufacturer Country: United States
Authorized Representative: SIEMENS HEALTHCARE LIMITED

Product details

Intended Use: This product is used with a DCA analyzer as a quality control method for microalbumin/creatinine analysis.
Product Type (Level 1): A Clinical chemistry and clinical toxicology
Product Type (Level 2): A.1660 Quality control materials (analytical and non-analytical)
Import Information: Contract manufacturing;; input

Dates and status

Registration Date: Mar 08, 2019
Expiry Date: Mar 08, 2029

About this record

Access comprehensive regulatory information for "Siemens" microalbumin/creatinine tube solution in Taiwan's medical device market through Pure Global AI's free database. This Risk Class 2 medical device is registered under number d8a797f9a5dc08e99d871d53c58b90fc and manufactured by SIEMENS HEALTHCARE DIAGNOSTICS INC.;; FISHER DIAGNOSTICS. The authorized representative in Taiwan is SIEMENS HEALTHCARE LIMITED.

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