Taiwan FDA registration 88f810fd28d1c437a3dbf711aacecf1d

"Siemens" rheumatoid factor test reagent

TW: “西門子” 類風濕因子檢驗試劑

Taiwan·Risk Class 2·RANDOX LABORATORIES LTD.;; Siemens Healthcare Diagnostics Inc.·Registered Jan 07, 2019 – Jan 07, 2029Active

Registration details

Analysis ID: 88f810fd28d1c437a3dbf711aacecf1d
Customs Code: DHA05603200606

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 diagnostics and needs to be used with Atellica CH Analyzer to quantitatively detect rheumatoid factor in human serum.
Product Type (Level 1): C Immunology and microbiology
Product Type (Level 2): C.5775 類風濕性因子免疫試驗系統
Import Information: Input;; Contract manufacturing

Dates and status

Registration Date: Jan 07, 2019
Expiry Date: Jan 07, 2029

About this record

Access comprehensive regulatory information for "Siemens" rheumatoid factor 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 88f810fd28d1c437a3dbf711aacecf1d and manufactured by RANDOX LABORATORIES LTD.;; Siemens Healthcare Diagnostics Inc.. The authorized representative in Taiwan is SIEMENS HEALTHCARE LIMITED.

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