Taiwan FDA registration 32c108ba775f11b72f531c3b7523a5cb

"Siemens" β2-microglobulin reagent group

TW: “西門子” β2-微球蛋白試劑組

Taiwan·Risk Class 2·RANDOX LABORATORIES LTD.;; Siemens Healthcare Diagnostics Inc.·Registered Nov 30, 2018 – Nov 30, 2028Active

Registration details

Analysis ID: 32c108ba775f11b72f531c3b7523a5cb
Customs Code: DHA05603181600

Company information

Manufacturer: RANDOX LABORATORIES LTD.;; Siemens Healthcare Diagnostics Inc.
Manufacturer Country: United Kingdom;;United States
Authorized Representative: SIEMENS HEALTHCARE LIMITED

Product details

Intended Use: This product is used for in vitro diagnosis and needs to be used with Atellica CH Analyzer to quantitatively detect β2-microglobulin in human serum and plasma (heparin lithium, EDTA potassium salt).
Product Type (Level 1): A Clinical Chemistry and Clinical Toxicology;; C Immunology and Microbiology
Product Type (Level 2): C.5630 β-2-微球蛋白免疫試驗系統;; A.1150 校正品
Import Information: import

Dates and status

Registration Date: Nov 30, 2018
Expiry Date: Nov 30, 2028

About this record

Access comprehensive regulatory information for "Siemens" β2-microglobulin reagent group in Taiwan's medical device market through Pure Global AI's free database. This Risk Class 2 medical device is registered under number 32c108ba775f11b72f531c3b7523a5cb and manufactured by RANDOX LABORATORIES LTD.;; Siemens Healthcare Diagnostics Inc.. The authorized representative in Taiwan is SIEMENS HEALTHCARE LIMITED.

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