Taiwan FDA registration ba8bbde6d10148b03044f6cc3045c505
"Loren" anti-human globulin serum reagent (clear or green)
TW: “羅倫”抗人類球蛋白血清試劑(透明或綠色)
Taiwan·Risk Class 2·Lorne Laboratories Limited·Registered May 16, 2019 – May 16, 2029ActiveRegistration details
- Analysis ID
- ba8bbde6d10148b03044f6cc3045c505
- Customs Code
- DHA05603243401
Company information
- Manufacturer
- Lorne Laboratories Limited
- Manufacturer Country
- United Kingdom
- Authorized Representative
- GLORY BIOSCIENCE CO., LTD.
Product details
- Intended Use
- Used for direct or indirect antiglobulin testing to detect IgG and/or complement C3 bound to erythrocyte cells.
- Product Type (Level 1)
- B Hematology, pathology, and genetics
- Product Type (Level 2)
- B.4020 Analysis of specific tests
- Import Information
- Input;; QMS/QSD
Dates and status
- Registration Date
- May 16, 2019
- Expiry Date
- May 16, 2029
About this record
Access comprehensive regulatory information for "Loren" anti-human globulin serum reagent (clear or green) in Taiwan's medical device market through Pure Global AI's free database. This Risk Class 2 medical device is registered under number ba8bbde6d10148b03044f6cc3045c505 and manufactured by Lorne Laboratories Limited. The authorized representative in Taiwan is GLORY BIOSCIENCE CO., LTD..
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