Taiwan FDA registration 89e215b5dd96bf6df622b3e3e505ca2d
DAJI automatic nucleic acid analysis system
TW: 達基全自動核酸分析系統
Registration details
- Analysis ID
- 89e215b5dd96bf6df622b3e3e505ca2d
Company information
- Manufacturer
- Dal Biotechnology Co., Ltd. Zhongli Plant
- 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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