Xpert®CT/NG Assay - ARCSA Registration b7e0ca6ad2da63cce2ee645b4a9627fd
Access comprehensive regulatory information for Xpert®CT/NG Assay in the Ecuador medical device market through Pure Global AI's free database. This III medical device is registered under ARCSA ID b7e0ca6ad2da63cce2ee645b4a9627fd and manufactured by CEPHEID AB. The device was registered on March 18, 2016.
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
b7e0ca6ad2da63cce2ee645b4a9627fd
Xpert®CT/NG Assay
ARCSA ID: b7e0ca6ad2da63cce2ee645b4a9627fd
Device Classification
Risk Class
III
Product Type
In Vitro Diagnostic
Brand Name
CEPHEID
Commercial Name
IVD Reagents/Kits, Molecular Assay, Infection, Bacteria, Chlamydia trachomatis/Neisseria gonorrhoeae, DNA
Sterilization Method
BIOLOGIA MOLECULAR PCR
Registration Information
Analysis ID
b7e0ca6ad2da63cce2ee645b4a9627fd
Registration Date
March 18, 2016
Expiration Date
March 18, 2026
Creation Date
February 17, 2021
Product Use
FOR THE DIAGNOSIS OF UROGENITAL DISEASE DUE TO CHLAMYDIA AND GONORRHEA
Manufacturer
Product Owner
Name
CEPHEID AB
Country
SWEDEN
Authorized Representative
Address
TODOS LOS SANTOS # 201 AND AV. JORGE PEREZ CONCHA
Phone
2610680