Taiwan FDA registration b940fcc5683ee05b68443f5cf36d78d1

Quidel Solana Instrument

TW: “快得利” 索拉娜核酸快速檢測儀
Taiwan flagTaiwan·Risk Class 2·MD·QUIDEL CORPORATION·Registered Feb 27, 2018 – Feb 27, 2023Expired
Registration details
Analysis ID
b940fcc5683ee05b68443f5cf36d78d1
License Form
Ministry of Health Medical Device Import No. 030510
Customs Code
DHA05603051007
Company information
Manufacturer
QUIDEL CORPORATION
Manufacturer Country
United States
Authorized Representative
BIO-CHECK LABORATORIES LTD.
Product details
Intended Use
This product is a rapid detector with constant temperature nucleic acid amplification reaction and fluorescent probe, which is suitable for analyzing Solana nucleic acid rapid detection series to assist patient diagnosis.
Product Type (Level 1)
A Clinical chemistry and clinical toxicology
Product Type (Level 2)
A2570 Clinical Multi-standard Detection System Instrument
Import Information
Imported from abroad
Dates and status
Registration Date
Feb 27, 2018
Expiry Date
Feb 27, 2023
About this record

Access comprehensive regulatory information for Quidel Solana Instrument in Taiwan's medical device market through Pure Global AI's free database. This Risk Class 2 medical device is registered under number b940fcc5683ee05b68443f5cf36d78d1 and manufactured by QUIDEL CORPORATION. The authorized representative in Taiwan is BIO-CHECK LABORATORIES LTD..

This page provides complete technical specifications, regulatory compliance details. Pure Global AI offers free access to 89,000+ Taiwan medical device registrations, helping global MedTech companies navigate Taiwan FDA regulations, identify competitors, and discover partnership opportunities efficiently.

Free DatabasePowered by Pure Global AI89,000+ Devices