Taiwan FDA registration 38e19b0177c640cdb71cbe17f1ff0d6a

Norfaferrite cytomegalovirus immunoglobulin G enzyme immunoassay kit

TW: 諾法鐵巨細胞病毒免疫球蛋白G酵素免疫分析試劑套組

Taiwan·Risk Class 2·GOLD STANDARD DIAGNOSTICS FRANKFURT GMBH·Registered Aug 28, 2020 – Aug 28, 2025Expired

Registration details

Analysis ID: 38e19b0177c640cdb71cbe17f1ff0d6a
Customs Code: DHA05603354107

Company information

Manufacturer: GOLD STANDARD DIAGNOSTICS FRANKFURT GMBH
Manufacturer Country: Germany
Authorized Representative: EVERLIGHT BIOTECH(TAIWAN) CO., LTD.

Product details

Intended Use: This set is a qualitative test for the detection of anti-cytomegalovirus (CMV) immunoglobulin G in human serum or plasma.
Product Type (Level 1): C Immunology and microbiology
Product Type (Level 2): C.3175 巨細胞病毒血清試劑
Import Information: QMS/QSD;; 輸入

Dates and status

Registration Date: Aug 28, 2020
Expiry Date: Aug 28, 2025

About this record

Access comprehensive regulatory information for Norfaferrite cytomegalovirus immunoglobulin G enzyme immunoassay kit in Taiwan's medical device market through Pure Global AI's free database. This Risk Class 2 medical device is registered under number 38e19b0177c640cdb71cbe17f1ff0d6a and manufactured by GOLD STANDARD DIAGNOSTICS FRANKFURT GMBH. The authorized representative in Taiwan is EVERLIGHT BIOTECH(TAIWAN) CO., LTD..

This page provides complete technical specifications, regulatory compliance details. Pure Global AI offers free access to 89,000+ Taiwan medical device registrations, helping global MedTech companies navigate Taiwan FDA regulations, identify competitors, and discover partnership opportunities efficiently.