Taiwan FDA registration 2e8777983884f4597951f35c021efdd3

"Remeng" Wickerella* bacterial antigen detection kit

TW: “銳盟”威克菌*細菌抗原檢測套組

Taiwan·Risk Class 2·REMEL EUROPE LIMITED·Registered Dec 07, 2005 – Dec 07, 2025Expired

Registration details

Analysis ID: 2e8777983884f4597951f35c021efdd3
Customs Code: DHA00601530704

Company information

Manufacturer: REMEL EUROPE LIMITED
Manufacturer Country: United Kingdom
Authorized Representative: THERMO FISHER SCIENTIFIC TAIWAN CO., LTD.

Product details

Intended Use: The Victocks* Bacterial Antigen Identification Kit provides a range of rapid latex reagents for the quantitative detection of Strptococcus group B, Haemophilus influenzxa type b, Streptococcus pneumoniae, Neisseria meningitis A, B, C, Y or W135 and Escherechia coli K1 that appears in cerebrospinal fluid at the time of infection. This kit can also detect Neisser meningitis B or E. coli type K1 cultured with antigens and culture media cultures of the above bacteria in other body fluids or blood culture supernatants.
Product Type (Level 1): C Immunology and microbiology
Product Type (Level 2): C.3390 奈瑟氏菌屬直接血清試劑
Import Information: import

Dates and status

Registration Date: Dec 07, 2005
Expiry Date: Dec 07, 2025

About this record

Access comprehensive regulatory information for "Remeng" Wickerella* bacterial antigen detection kit in Taiwan's medical device market through Pure Global AI's free database. This Risk Class 2 medical device is registered under number 2e8777983884f4597951f35c021efdd3 and manufactured by REMEL EUROPE LIMITED. The authorized representative in Taiwan is THERMO FISHER SCIENTIFIC TAIWAN CO., LTD..

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