Taiwan FDA registration c9112a63e1acb27a594fa2495a18bbe6

"Eprocex" anti-K blood group reagent (monoclonal antibody) (IgG)

TW: “依免可”抗k血型試劑(單株抗體)(IgG)

Taiwan·Risk Class 2·IMMUCOR, INC.·Registered Dec 30, 2020 – Dec 30, 2025Expired

Registration details

Analysis ID: c9112a63e1acb27a594fa2495a18bbe6
Customs Code: DHA05603418200

Company information

Manufacturer: IMMUCOR, INC.
Manufacturer Country: United States
Authorized Representative: Y.H. BIOTEK CO., LTD.

Product details

Intended Use: This product uses indirect agglutination to detect k (KEL2) antigen on red blood 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: Dec 30, 2020
Expiry Date: Dec 30, 2025

About this record

Access comprehensive regulatory information for "Eprocex" anti-K blood group reagent (monoclonal antibody) (IgG) in Taiwan's medical device market through Pure Global AI's free database. This Risk Class 2 medical device is registered under number c9112a63e1acb27a594fa2495a18bbe6 and manufactured by IMMUCOR, INC.. The authorized representative in Taiwan is Y.H. BIOTEK CO., LTD..

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