Taiwan FDA registration 53ad617dcad24284af41580bc3ea014c

"Siemens" immunoglobulin test reagent

TW: “西門子” 免疫球蛋白檢驗試劑

Taiwan·Risk Class 2·RANDOX LABORATORIES LTD.;; Siemens Healthcare Diagnostics Inc.·Registered Jan 09, 2019 – Jan 09, 2029Active

Registration details

Analysis ID: 53ad617dcad24284af41580bc3ea014c
Customs Code: DHA05603202204

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 with Atellica CH Analyzer to quantitatively detect immunoglobulin A (IgA) in human serum and plasma (heparin lithium).
Product Type (Level 1): C Immunology and microbiology
Product Type (Level 2): C.5510 免疫球蛋白A,G,M,D及E免疫試驗系統
Import Information: import

Dates and status

Registration Date: Jan 09, 2019
Expiry Date: Jan 09, 2029

About this record

Access comprehensive regulatory information for "Siemens" immunoglobulin 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 53ad617dcad24284af41580bc3ea014c and manufactured by RANDOX LABORATORIES LTD.;; Siemens Healthcare Diagnostics Inc.. The authorized representative in Taiwan is SIEMENS HEALTHCARE LIMITED.

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