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Abbott Designer Herpes simplex virus type 1 IgG antibody test set - Taiwan Registration b07f8c1933f374d608c94e3c18e205ec

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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b07f8c1933f374d608c94e3c18e205ec
Registration Details
Taiwan FDA Registration: b07f8c1933f374d608c94e3c18e205ec
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Device Details

Abbott Designer Herpes simplex virus type 1 IgG antibody test set
TW: ไบžๅŸน่จญ่จˆๅธซๅ–ฎ็ด”็šฐ็–น็—…ๆฏ’็ฌฌ1ๅž‹IgG ๆŠ—้ซ”ๆชข้ฉ—่ฉฆๅŠ‘็ต„
Risk Class 2

Registration Details

b07f8c1933f374d608c94e3c18e205ec

DHA05603620802

Company Information

Product Details

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.

A Clinical Chemistry and Clinical Toxicology;; C Immunology and Microbiology

C.3305 Serological analysis of monopolitic rash virus;; A.1660 Quality control materials (analytical and non-analytical); A.1150 calibration

ๅง”่จ—่ฃฝ้€ ;; QMS/QSD;; ่ผธๅ…ฅ

Dates and Status

Aug 04, 2023

Aug 04, 2028