Abbott Designer Herpes simplex virus type 1 IgG antibody test set
Taiwan·Risk Class 2·ABBOTT IRELAND DIAGNOSTICS DIVISION;; BIOKIT, S.A.·Registered Aug 04, 2023 – Aug 04, 2028Active- Analysis ID
- b07f8c1933f374d608c94e3c18e205ec
- Customs Code
- DHA05603620802
- Manufacturer Country
- Ireland;;Spain
- Authorized Representative
- ABBOTT LABORATORIES SERVICES LLC TAIWAN BRANCH (U.S.A.)
- Intended Use
- This product is used for the qualitative detection of herpes simplex virus type 1 (HSV-1)-specific IgG antibodies in human serum and plasma by chemical cold light particle immunoassay (CMIA) on the ARCHITECT i system.
- 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
- 委託製造;; QMS/QSD;; 輸入
- Registration Date
- Aug 04, 2023
- Expiry Date
- Aug 04, 2028
Access comprehensive regulatory information for Abbott Designer 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 b07f8c1933f374d608c94e3c18e205ec 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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