Taiwan FDA registration 07c0cc4a18529b1b4a754940f4f448ed

"Kaijie" is a nucleic acid test group for brain inflammation/encephalitis pathogens

TW: "凱杰" 腦膜炎/腦炎病原體多標的核酸檢測試劑組

Taiwan·Risk Class 2·STAT Dx Life S.L;; QIAGEN GMBH·Registered Mar 14, 2024 – Mar 14, 2029Active

Registration details

Analysis ID: 07c0cc4a18529b1b4a754940f4f448ed
Customs Code: DHA05603706903

Company information

Manufacturer: STAT Dx Life S.L;; QIAGEN GMBH
Manufacturer Country: Spain;;Germany
Authorized Representative: QIAGEN TAIWAN COMPANY LIMITED

Product details

Intended Use: This product is a multiplex nucleic acid qualitative in vitro diagnostic test for the QIAstat-Dx System. This product can simultaneously detect and identify a variety of bacterial, viral, or yeast nucleic acids from cerebrospinal fluid (CSF) samples obtained by lumbar puncture in patients with meningitis and/or encephalitis symptoms and/or symptoms.
Product Type (Level 1): C Immunology and microbiology
Product Type (Level 2): C.3970 Nucleic acid detection system for the detection and identification of microbial pathogens in cerebrospinal fluid
Import Information: 委託製造;; QMS/QSD;; 輸入

Dates and status

Registration Date: Mar 14, 2024
Expiry Date: Mar 14, 2029

About this record

Access comprehensive regulatory information for "Kaijie" is a nucleic acid test group for brain inflammation/encephalitis pathogens in Taiwan's medical device market through Pure Global AI's free database. This Risk Class 2 medical device is registered under number 07c0cc4a18529b1b4a754940f4f448ed and manufactured by STAT Dx Life S.L;; QIAGEN GMBH. The authorized representative in Taiwan is QIAGEN TAIWAN COMPANY LIMITED.

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