Taiwan FDA registration 090ddfadefa131243eb477d778fe9abd
Gene ASPAT Real-Time Detection PCR Analyzer
TW: 基因艾斯柏特即時偵測 PCR 分析儀
Taiwan·Risk Class 2·CEPHEID;; Sanmina·Registered Oct 20, 2023 – Oct 20, 2028ActiveRegistration details
- Analysis ID
- 090ddfadefa131243eb477d778fe9abd
- Customs Code
- DHA05603623005
Company information
- Manufacturer
- CEPHEID;; Sanmina
- Manufacturer Country
- United States
- Authorized Representative
- PROGRESSIVE GROUP INC.
Product details
- Intended Use
- This product is intended to be used with the Cepheid Xpert Assay Kit as an in vitro diagnostic (IVD) medical device. This product automates sample preparation and uses real-time polymerization chain reaction (PCR) for nucleic acid amplification and target sequence detection.
- Product Type (Level 1)
- A Clinical chemistry and clinical toxicology
- Product Type (Level 2)
- A.2570 Clinical Multi-standard Detection System Instrument
- Import Information
- 輸入;; QMS/QSD;; 委託製造
Dates and status
- Registration Date
- Oct 20, 2023
- Expiry Date
- Oct 20, 2028
About this record
Access comprehensive regulatory information for Gene ASPAT Real-Time Detection PCR Analyzer in Taiwan's medical device market through Pure Global AI's free database. This Risk Class 2 medical device is registered under number 090ddfadefa131243eb477d778fe9abd and manufactured by CEPHEID;; Sanmina. The authorized representative in Taiwan is PROGRESSIVE GROUP INC..
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