Xpert Xpress Strep A - ARCSA Registration 5598d9133faceb703685f4f076c64af3
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.
Free Database
Powered by Pure Global AI
ARCSA Official Data
III
5598d9133faceb703685f4f076c64af3
Xpert Xpress Strep A
ARCSA ID: 5598d9133faceb703685f4f076c64af3
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
Product Use
QUALITATIVE IN VITRO DIAGNOSTIC TEST FOR THE DETECTION OF STREPTOCOCCUS PYOGENES IN SWAB SAMPLES
Manufacturer
Product Owner
Name
CEPHEID
Country
UNITED STATES
Authorized Representative
Address
TODOS LOS SANTOS # 201 AND AV. JORGE PEREZ CONCHA
Phone
2610680