Taiwan FDA registration 45cdcfd52736df6fe51434736cac50a2

"Loren" monostrain antibody anti-Jkb serum reagent

TW: “羅倫” 單株抗體抗Jkb血清試劑

Taiwan·Risk Class 2·Lorne Laboratories Limited·Registered Oct 07, 2020 – Oct 07, 2025Expired

Registration details

Analysis ID: 45cdcfd52736df6fe51434736cac50a2
Customs Code: DHA05603368505

Company information

Manufacturer: Lorne Laboratories Limited
Manufacturer Country: United Kingdom
Authorized Representative: GLORY BIOSCIENCE CO., LTD.

Product details

Intended Use: This product is a blood typing reagent designed to qualitatively determine the presence of Jkb antigen on red blood cells of donors or patients requiring blood transfusions when tested according to the recommended techniques described in the imitation sheet.
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: Oct 07, 2020
Expiry Date: Oct 07, 2025

About this record

Access comprehensive regulatory information for "Loren" monostrain antibody anti-Jkb serum reagent in Taiwan's medical device market through Pure Global AI's free database. This Risk Class 2 medical device is registered under number 45cdcfd52736df6fe51434736cac50a2 and manufactured by Lorne Laboratories Limited. The authorized representative in Taiwan is GLORY BIOSCIENCE CO., LTD..

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