Taiwan FDA registration b32fe8e3c0dc4881d1fb0b8b2fa78d08

"Quick Test" Urine Antigen Rapid Diagnostic Reagent for Pneumonia in Veterans (Unsterilized)

TW: "速測" 退伍軍人肺炎尿液抗原快速診斷試劑 (未滅菌)

Taiwan·Risk Class 1·CERTEST BIOTEC, S.L.·Registered Dec 22, 2016 – Dec 22, 2021Cancelled

Registration details

Analysis ID: b32fe8e3c0dc4881d1fb0b8b2fa78d08
Customs Code: DHA09401733009

Company information

Manufacturer: CERTEST BIOTEC, S.L.
Manufacturer Country: Spain
Authorized Representative: JOLEX INTERNATIONAL CO., LTD.

Product details

Intended Use: Limit the management method of medical equipment Haemophilus serogenus (C.3300) first level identification range.
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: import

Dates and status

Registration Date: Dec 22, 2016
Expiry Date: Dec 22, 2021
Cancellation Date: Mar 15, 2022

Cancellation information

Status: Logged out
Reason: 屆期未申請展延;;自請註銷

About this record

Access comprehensive regulatory information for "Quick Test" Urine Antigen Rapid Diagnostic Reagent for Pneumonia in Veterans (Unsterilized) in Taiwan's medical device market through Pure Global AI's free database. This Risk Class 1 medical device is registered under number b32fe8e3c0dc4881d1fb0b8b2fa78d08 and manufactured by CERTEST BIOTEC, S.L.. The authorized representative in Taiwan is JOLEX INTERNATIONAL CO., LTD..

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