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Alethia Group B Streptococcus (GBS) - ARCSA Registration a6040145c039247d3265fce6b4ea4463

Access comprehensive regulatory information for Alethia Group B Streptococcus (GBS) in the Ecuador medical device market through Pure Global AI's free database. This III medical device is registered under ARCSA ID a6040145c039247d3265fce6b4ea4463 and manufactured by MERIDIAN BIOSCIENCE, INC.. The device was registered on September 13, 2019.

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
III
a6040145c039247d3265fce6b4ea4463
Alethia Group B Streptococcus (GBS)
ARCSA ID: a6040145c039247d3265fce6b4ea4463
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Device Classification
Risk Class
III
Product Type
In Vitro Diagnostic
Brand Name
MERIDIAN
Commercial Name
19-238 IVD Reagents/Kits, Molecular Assay, Infection, Bacteria
Sterilization Method
8.- MOLECULAR DIAGNOSIS
Registration Information
Analysis ID
a6040145c039247d3265fce6b4ea4463
Registration Date
September 13, 2019
Expiration Date
September 13, 2024
Creation Date
September 13, 2019
Product Use

FOR THE DETECTION OF STREPTOCOCCUS AGALACTIAE IN ENRICHED CULTURES OBTAINED FROM VAGINAL/RECTAL SWAB SAMPLES FROM WOMEN.

Manufacturer
City
CINCINNATI
Country
UNITED STATES
Address
3471 RIVER HILLS DRIVE, CINCINNATI, OH 45244 UNITED STATES
Product Owner
Name
MERIDIAN BIOSCIENCE, INC.
Country
UNITED STATES
Authorized Representative
Address
CALLE PARAISO NUMERO OE 5-468 Y EL EDEN
Phone
23430753