Taiwan FDA registration f8b0035620efa86d6c5c1fad284e7437

Norfaferite cytomegalovirus immunoglobulin M enzyme immunoassay kit

TW: 諾法鐵巨細胞病毒免疫球蛋白M酵素免疫分析試劑套組

Taiwan·Risk Class 2·GOLD STANDARD DIAGNOSTICS FRANKFURT GMBH·Registered Dec 09, 2021 – Dec 09, 2026Active

Registration details

Analysis ID: f8b0035620efa86d6c5c1fad284e7437
Customs Code: DHA05603491807

Company information

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

Product details

Intended Use: This kit is used for the qualitative detection of anti-cytomegalovirus (CMV) immunoglobulin M antibodies in human serum or plasma (citric acid, heparin).
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: Dec 09, 2021
Expiry Date: Dec 09, 2026

About this record

Access comprehensive regulatory information for Norfaferite cytomegalovirus immunoglobulin M 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 f8b0035620efa86d6c5c1fad284e7437 and manufactured by GOLD STANDARD DIAGNOSTICS FRANKFURT GMBH. The authorized representative in Taiwan is EVERLIGHT BIOTECH(TAIWAN) CO., LTD..

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