Taiwan FDA registration a2ee8ab3fd40f3877b12d99e94b4b9df

"Kaijie" multiple pathogen diagnosis system

TW: “凱杰” 多重病原診斷系統

Taiwan·Risk Class 2·LRE MEDICAL GMBH;; QIAGEN GMBH·Registered Jun 29, 2021 – Jun 29, 2026Expired

Registration details

Analysis ID: a2ee8ab3fd40f3877b12d99e94b4b9df
Customs Code: DHA05603467303

Company information

Manufacturer: LRE MEDICAL GMBH;; QIAGEN GMBH
Manufacturer Country: Germany
Authorized Representative: QIAGEN TAIWAN COMPANY LIMITED

Product details

Intended Use: 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.
Product Type (Level 1): A Clinical chemistry and clinical toxicology
Product Type (Level 2): A.2570 Clinical Multi-standard Detection System Instrument
Import Information: 委託製造;; 輸入;; QMS/QSD

Dates and status

Registration Date: Jun 29, 2021
Expiry Date: Jun 29, 2026

About this record

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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