Revogene Strep A test kit - ARCSA Registration 0a031edecbf1b3d8b6757982a54892d4
Access comprehensive regulatory information for Revogene Strep A test kit in the Ecuador medical device market through Pure Global AI's free database. This II medical device is registered under ARCSA ID 0a031edecbf1b3d8b6757982a54892d4 and manufactured by MERIDIAN BIOSCIENCE, INC.. The device was registered on April 12, 2022.
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.
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ARCSA Official Data
II
0a031edecbf1b3d8b6757982a54892d4
Revogene Strep A test kit
ARCSA ID: 0a031edecbf1b3d8b6757982a54892d4
Device Classification
Risk Class
II
Product Type
In Vitro Diagnostic
Brand Name
REVOGENE
Commercial Name
19-238 IVD Reagents/Kits, Molecular Assay, Infection, Bacteria
Sterilization Method
MOLECULAR DIAGNOSIS
Registration Information
Analysis ID
0a031edecbf1b3d8b6757982a54892d4
Registration Date
April 12, 2022
Expiration Date
April 12, 2027
Creation Date
December 04, 2022
Product Use
DIRECT DETECTION OF NUCLEIC ACIDS OF STREPTOCOCCUS PYOGENES (STREPTOCOCCUS ฮ-HEMOLITICO GROUP A)
Manufacturer
City
CINCINNATI
Country
UNITED STATES
Address
3471 RIVER HILLS DRIVE, CINCINNATI, OH 45244 USA
Product Owner
Name
MERIDIAN BIOSCIENCE, INC.
Country
UNITED STATES
Authorized Representative