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"Kaijie" multiple pathogen diagnosis system - Taiwan Registration a2ee8ab3fd40f3877b12d99e94b4b9df

Access comprehensive regulatory information for "Kaijie" multiple pathogen diagnosis system in Taiwan's medical device market through Pure Global AI's free database. This Risk Class 2 medical device is registered under number a2ee8ab3fd40f3877b12d99e94b4b9df and manufactured by LRE MEDICAL GMBH;; QIAGEN GMBH. The authorized representative in Taiwan is QIAGEN TAIWAN COMPANY LIMITED.

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a2ee8ab3fd40f3877b12d99e94b4b9df
Registration Details
Taiwan FDA Registration: a2ee8ab3fd40f3877b12d99e94b4b9df
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Device Details

"Kaijie" multiple pathogen diagnosis system
TW: โ€œๅ‡ฑๆฐโ€ ๅคš้‡็—…ๅŽŸ่จบๆ–ท็ณป็ตฑ
Risk Class 2

Registration Details

a2ee8ab3fd40f3877b12d99e94b4b9df

DHA05603467303

Company Information

Product Details

This product is used for in vitro diagnostics and to provide diagnostic results. All analytical steps are fully automated using molecular diagnostic QIAstat-Dx kits and real-time PCR assays. This product is for professional use only and is not intended for self-testing.

A Clinical chemistry and clinical toxicology

A.2570 Clinical Multi-standard Detection System Instrument

ๅง”่จ—่ฃฝ้€ ;; ่ผธๅ…ฅ;; QMS/QSD

Dates and Status

Jun 29, 2021

Jun 29, 2026