Taiwan FDA registration 1a789448e1cb73e42f4e1dcf10c5345b
"Siemens" α-1-antitrypsin assay reagent
TW: “西門子” α-1-抗胰蛋白酶分析試劑
Taiwan·Risk Class 2·RANDOX LABORATORIES LTD.;; Siemens Healthcare Diagnostics Inc.·Registered Dec 03, 2018 – Dec 03, 2028ActiveRegistration details
- Analysis ID
- 1a789448e1cb73e42f4e1dcf10c5345b
- Customs Code
- DHA05603195409
Company information
- Manufacturer Country
- United Kingdom;;United States
- Authorized Representative
- SIEMENS HEALTHCARE LIMITED
Product details
- Intended Use
- This product is used in vitro diagnostics with Atellica CH Analyzer to quantitatively detect α-1-antitrypsin in human serum and plasma (heparin lithium).
- Product Type (Level 1)
- C Immunology and microbiology
- Product Type (Level 2)
- C.5130 α-1-抗胰蛋白免疫試驗系統
- Import Information
- Input;; Contract manufacturing
Dates and status
- Registration Date
- Dec 03, 2018
- Expiry Date
- Dec 03, 2028
About this record
Access comprehensive regulatory information for "Siemens" α-1-antitrypsin assay reagent in Taiwan's medical device market through Pure Global AI's free database. This Risk Class 2 medical device is registered under number 1a789448e1cb73e42f4e1dcf10c5345b and manufactured by RANDOX LABORATORIES LTD.;; Siemens Healthcare Diagnostics Inc.. The authorized representative in Taiwan is SIEMENS HEALTHCARE LIMITED.
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