Taiwan FDA registration 181b0f457aa82398649c186c0f1f0248

Abbotchix Herpes simplex virus type 1 IgG antibody test set

TW: 亞培單純皰疹病毒第1型 IgG 抗體檢驗試劑組
Taiwan flagTaiwan·Risk Class 2·ABBOTT IRELAND DIAGNOSTICS DIVISION;; BIOKIT, S.A.·Registered May 26, 2023 – May 26, 2028Active
Registration details
Analysis ID
181b0f457aa82398649c186c0f1f0248
Customs Code
DHA05603618105
Company information
Manufacturer Country
Ireland;;Spain
Product details
Intended Use
This product is used for the qualitative detection of herpes simplex virus type 1 in human serum and plasma by chemical cold light particle immunoassay (CMIA) on the Alinity i system; HSV-1) Specific IgG antibodies.
Product Type (Level 1)
A Clinical Chemistry and Clinical Toxicology;; C Immunology and Microbiology
Product Type (Level 2)
C.3305 Serological analysis of monopolitic rash virus;; A.1660 Quality control materials (analytical and non-analytical); A.1150 calibration
Import Information
輸入;; QMS/QSD;; 委託製造
Dates and status
Registration Date
May 26, 2023
Expiry Date
May 26, 2028
About this record

Access comprehensive regulatory information for Abbotchix Herpes simplex virus type 1 IgG antibody test set in Taiwan's medical device market through Pure Global AI's free database. This Risk Class 2 medical device is registered under number 181b0f457aa82398649c186c0f1f0248 and manufactured by ABBOTT IRELAND DIAGNOSTICS DIVISION;; BIOKIT, S.A.. The authorized representative in Taiwan is ABBOTT LABORATORIES SERVICES LLC TAIWAN BRANCH (U.S.A.).

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