Taiwan FDA registration 5bd2578ce61c7deaaf9395d2f6d76cbd

"Kipfu" Legionella pneumophila nucleic acid test reagent set (non-sterilized)

TW: "基普復" 嗜肺性退伍軍人桿菌核酸檢驗試劑組(未滅菌)

Taiwan·Risk Class 1·GeneProof a. s.·Registered Sep 22, 2023 – Sep 22, 2028Active

Registration details

Analysis ID: 5bd2578ce61c7deaaf9395d2f6d76cbd
Customs Code: DHA09402325507

Company information

Manufacturer: GeneProof a. s.
Manufacturer Country: Czechia
Authorized Representative: MEDTRI CO., LTD.

Product details

Intended Use: It is limited to the first-level identification scope of Haemophilus serum reagent (C.3300) in the classification and grading management method of medical devices.
Product Type (Level 1): C Immunology and microbiology
Product Type (Level 2): C.3300 嗜血桿菌屬血清試劑
Import Information: Input;; QMS/QSD

Dates and status

Registration Date: Sep 22, 2023
Expiry Date: Sep 22, 2028

About this record

Access comprehensive regulatory information for "Kipfu" Legionella pneumophila nucleic acid test reagent set (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 5bd2578ce61c7deaaf9395d2f6d76cbd and manufactured by GeneProof a. s.. The authorized representative in Taiwan is MEDTRI CO., LTD..

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