Taiwan FDA registration 2f9202f88c3f146e0ba5b2a44f8c0108

Apex β2 microglobulin assay set

TW: 亞培β2微球蛋白檢驗試劑組
Taiwan flagTaiwan·Risk Class 2·BIOKIT, S.A.·Registered Oct 06, 2020 – Oct 06, 2025Expired
Registration details
Analysis ID
2f9202f88c3f146e0ba5b2a44f8c0108
Customs Code
DHA05603368403
Company information
Manufacturer
BIOKIT, S.A.
Manufacturer Country
Spain
Product details
Intended Use
This product utilizes the Alinity c analyzer to quantitatively detect β2-microglobulin (β2M) in human serum or plasma samples.
Product Type (Level 1)
C Immunology and Microbiology; A Clinical chemistry and clinical toxicology
Product Type (Level 2)
C.5630 β-2-微球蛋白免疫試驗系統;; A.1150 校正品
Import Information
Input;; QMS/QSD
Dates and status
Registration Date
Oct 06, 2020
Expiry Date
Oct 06, 2025
About this record

Access comprehensive regulatory information for Apex β2 microglobulin assay set in Taiwan's medical device market through Pure Global AI's free database. This Risk Class 2 medical device is registered under number 2f9202f88c3f146e0ba5b2a44f8c0108 and manufactured by BIOKIT, S.A.. The authorized representative in Taiwan is ABBOTT LABORATORIES SERVICES LLC TAIWAN BRANCH (U.S.A.).

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