13c031c4132f35edff9ec1eea1ce44fe
Xpert® Xpress SARS-CoV-2
CEPHEID·III·Ecuador ARCSA·Registered April 02, 2020
Device classification
- Risk class
- III
- Product type
- In Vitro Diagnostic
- Brand name
- XPERT
- Commercial name
- IVD Reagents/Kits, Molecular Assay, Infection, Virus
- Sterilization method
- METHODOLOGY: MOLECULAR DIAGNOSIS
Registration information
- Analysis ID
- 13c031c4132f35edff9ec1eea1ce44fe
- Registration date
- April 02, 2020
- Expiration date
- April 02, 2025
- Creation date
- June 18, 2021
Manufacturer
- Name
- CEPHEID
- Country
- UNITED STATES
- Address
- 904 CARIBBEAN DRIVE SUNNYVALE CA, 94089 USA
Product owner
- Name
- CEPHEID
- Country
- UNITED STATES
Authorized representative
- Address
- TODOS LOS SANTOS # 201 AND AV. JORGE PEREZ CONCHA
- Phone
- 2610680
Product use
FOR THE QUALITATIVE DETECTION OF SARS-COV-2 NUCLEIC ACID IN PHARYNGEAL SWAB SAMPLES
About this record
Access comprehensive regulatory information for Xpert® Xpress SARS-CoV-2 in the Ecuador medical device market through Pure Global AI's free database. This III medical device is registered under ARCSA ID 13c031c4132f35edff9ec1eea1ce44fe and manufactured by CEPHEID. The device was registered on April 02, 2020.
This page provides complete registration details including product type (In Vitro Diagnostic), manufacturer information, authorized representative details, and regulatory compliance data from the official Ecuador ARCSA medical device database. Pure Global AI offers free access to Ecuador's complete medical device registry.