5598d9133faceb703685f4f076c64af3
Xpert Xpress Strep A
CEPHEID·III·Ecuador ARCSA·Registered January 27, 2020
Device classification
- Risk class
- III
- Product type
- In Vitro Diagnostic
- Brand name
- GENEXPERT
- Commercial name
- 19-183.-Reagents/Kits for IVD Assays, Serology, Bacteria, Streptococcus (Streptococcus) A, Antibodies, Pyogenic Toxin
- Sterilization method
- METHODOLOGY: MOLECULAR BIOLOGY
Registration information
- Analysis ID
- 5598d9133faceb703685f4f076c64af3
- Registration date
- January 27, 2020
- Expiration date
- January 27, 2025
- Creation date
- January 27, 2020
Manufacturer
- Name
- CEPHEID
- City
- SUNNYVALE, CA
- 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
QUALITATIVE IN VITRO DIAGNOSTIC TEST FOR THE DETECTION OF STREPTOCOCCUS PYOGENES IN SWAB SAMPLES
About this record
Access comprehensive regulatory information for Xpert Xpress Strep A in the Ecuador medical device market through Pure Global AI's free database. This III medical device is registered under ARCSA ID 5598d9133faceb703685f4f076c64af3 and manufactured by CEPHEID. The device was registered on January 27, 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.