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"Kaijie" is a nucleic acid test group for brain inflammation/encephalitis pathogens - Taiwan Registration 07c0cc4a18529b1b4a754940f4f448ed

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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07c0cc4a18529b1b4a754940f4f448ed
Registration Details
Taiwan FDA Registration: 07c0cc4a18529b1b4a754940f4f448ed
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Device Details

"Kaijie" is a nucleic acid test group for brain inflammation/encephalitis pathogens
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Risk Class 2

Registration Details

07c0cc4a18529b1b4a754940f4f448ed

DHA05603706903

Company Information

Spain;;Germany

Product Details

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.

C Immunology and microbiology

C.3970 Nucleic acid detection system for the detection and identification of microbial pathogens in cerebrospinal fluid

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Dates and Status

Mar 14, 2024

Mar 14, 2029