Taiwan FDA registration 44b3823d30696e51b0593b904a04a522

"Siemens" microalbumin reagent group

TW: “西門子” 微白蛋白試劑組

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

Registration details

Analysis ID: 44b3823d30696e51b0593b904a04a522
Customs Code: DHA05603202408

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 the Atellica CH analyzer to quantitatively detect albumin in human urine.
Product Type (Level 1): A Clinical Chemistry and Clinical Toxicology;; C Immunology and Microbiology
Product Type (Level 2): C.5040 白蛋白免疫試驗系統;; A.1150 校正品
Import Information: Contract manufacturing;; input

Dates and status

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

About this record

Access comprehensive regulatory information for "Siemens" microalbumin 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 44b3823d30696e51b0593b904a04a522 and manufactured by RANDOX LABORATORIES LTD.;; Siemens Healthcare Diagnostics Inc.. The authorized representative in Taiwan is SIEMENS HEALTHCARE LIMITED.

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