Taiwan FDA registration 6771831f39bc55aed4f283870970a849

Reagent for the detection of Herpes simplex virus type 1 specific IgG

TW: 禮雅尚單純皰疹病毒第一型特異IgG檢測試劑

Taiwan·Risk Class 2·DIASORIN INC.·Registered Aug 17, 2020 – Aug 17, 2025Expired

Registration details

Analysis ID: 6771831f39bc55aed4f283870970a849
Customs Code: DHA05603352904

Company information

Manufacturer: DIASORIN INC.
Manufacturer Country: United States
Authorized Representative: MEDRICH INSTRUMENT CO., LTD.

Product details

Intended Use: This product uses chemical cold light immunoassay (CLIA) with Reap Analyzer and Reasan XL Analyzer to qualitatively determine herpes simplex virus type 1 specific IgG antibodies in human serum samples.
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)
Import Information: QMS/QSD;; 輸入

Dates and status

Registration Date: Aug 17, 2020
Expiry Date: Aug 17, 2025

About this record

Access comprehensive regulatory information for Reagent for the detection of Herpes simplex virus type 1 specific IgG in Taiwan's medical device market through Pure Global AI's free database. This Risk Class 2 medical device is registered under number 6771831f39bc55aed4f283870970a849 and manufactured by DIASORIN INC.. The authorized representative in Taiwan is MEDRICH INSTRUMENT CO., LTD..

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