Taiwan FDA registration c96c765d0c0c48fecb3ac5f4c5de1c3c

“Cepheid” Xpert C. difficile/Epi

TW: “賽沛” 困難梭狀芽孢桿菌檢測套組

Taiwan·Risk Class 2·MD·CEPHEID·Registered Oct 01, 2018 – Oct 01, 2028Active

Registration details

Analysis ID: c96c765d0c0c48fecb3ac5f4c5de1c3c
License Form: Ministry of Health Medical Device Import No. 031487
Customs Code: DHA05603148704

Company information

Manufacturer: CEPHEID
Manufacturer Country: United States
Authorized Representative: PROGRESSIVE GROUP INC.

Product details

Intended Use: This product is an in vitro diagnostic reagent using the GeneXpert instrument system to quickly detect and quantify the absence of deletion of the 177th nucleotide of Clostridium difficile tcdB (toxin B gene), cdt (binary toxin gene) and tcdC gene using the GeneXpert instrument system, using unformed (liquid or soft texture) feces of patients with suspected Clostridium difficile infection.
Product Type (Level 1): C Immunology and microbiology devices
Product Type (Level 2): C3130 困難梭狀桿菌毒素(ClostridiumDifficileToxin)基因擴增試劑
Import Information: Imported from abroad

Dates and status

Registration Date: Oct 01, 2018
Expiry Date: Oct 01, 2028

About this record

Access comprehensive regulatory information for “Cepheid” Xpert C. difficile/Epi in Taiwan's medical device market through Pure Global AI's free database. This Risk Class 2 medical device is registered under number c96c765d0c0c48fecb3ac5f4c5de1c3c and manufactured by CEPHEID. The authorized representative in Taiwan is PROGRESSIVE GROUP INC..

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