Taiwan FDA registration 89e215b5dd96bf6df622b3e3e505ca2d

DAJI automatic nucleic acid analysis system

TW: 達基全自動核酸分析系統
Taiwan flagTaiwan·Risk Class 2·Dal Biotechnology Co., Ltd. Zhongli Plant·Registered Aug 02, 2022 – Aug 02, 2027Active
Registration details
Analysis ID
89e215b5dd96bf6df622b3e3e505ca2d
Company information
Manufacturer Country
Taiwan, Province of China
Authorized Representative
DELBIO INC.
Product details
Intended Use
This product can perform automated nucleic acid extraction and qualitative analysis of the nucleic acid sequence of interest using real-time PCR technology.
Product Type (Level 1)
C Immunology and Microbiology; A Clinical chemistry and clinical toxicology
Product Type (Level 2)
C.4070 Ribonucleic acid analysis pretreatment system;; A.2570 Clinical Multi-standard Detection System Instrument
Import Information
QMS/QSD;; 國產
Dates and status
Registration Date
Aug 02, 2022
Expiry Date
Aug 02, 2027
About this record

Access comprehensive regulatory information for DAJI automatic nucleic acid analysis system in Taiwan's medical device market through Pure Global AI's free database. This Risk Class 2 medical device is registered under number 89e215b5dd96bf6df622b3e3e505ca2d and manufactured by Dal Biotechnology Co., Ltd. Zhongli Plant. The authorized representative in Taiwan is DELBIO INC..

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