Taiwan FDA registration 438df75678564e291e25607516d8ed1a

Clostridium difficile antigen detection reagent (non-sterilized)

TW: 聯華困難梭狀芽孢桿菌抗原檢測試劑(未滅菌)

Taiwan·Risk Class 1·FIRSTEP BIORESEARCH INC.·Registered Oct 08, 2024 – Oct 08, 2029Active

Registration details

Analysis ID: 438df75678564e291e25607516d8ed1a

Company information

Manufacturer: FIRSTEP BIORESEARCH INC.
Manufacturer Country: Taiwan, Province of China
Authorized Representative: FIRSTEP BIORESEARCH INC.

Product details

Intended Use: It is limited to the first level of identification scope of microbial identification and measurement equipment (C.2660) of the Measures for the Classification and Grading of Medical Devices.
Product Type (Level 1): C Immunology and microbiology
Product Type (Level 2): C.2660 微生物鑑別及測定器材
Import Information: QMS/QSD;; 國產

Dates and status

Registration Date: Oct 08, 2024
Expiry Date: Oct 08, 2029

About this record

Access comprehensive regulatory information for Clostridium difficile antigen detection reagent (non-sterilized) in Taiwan's medical device market through Pure Global AI's free database. This Risk Class 1 medical device is registered under number 438df75678564e291e25607516d8ed1a and manufactured by FIRSTEP BIORESEARCH INC.. The authorized representative in Taiwan is FIRSTEP BIORESEARCH INC..

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