Pure Global
478fc44a0077ddc9425b4cb8c20057d1

Xpert® HIV-1 Qual XC

CEPHEID AB·III·Ecuador ARCSA·Registered April 01, 2022
Device classification
Risk class
III
Product type
In Vitro Diagnostic
Brand name
Xpert
Commercial name
19-245.- Reagents/Kits for IVD Assays, Molecular Assay, Infection, Virus, Retrovirus, HIV
Sterilization method
METHODOLOGY: MOLECULAR DIAGNOSIS
Registration information
Analysis ID
478fc44a0077ddc9425b4cb8c20057d1
Registration date
April 01, 2022
Expiration date
April 01, 2027
Creation date
January 04, 2022
Manufacturer
Name
CEPHEID AB
City
LONDON
Country
SWEDEN
Address
RONTGENVAGEN 5 SE-171 54 SOLNA - SWEDEN
Product owner
Name
CEPHEID AB
Country
SWEDEN
Authorized representative
Name
HEALTH SYSTEMS ROCARSYSTEM S.A.
Address
TODOS LOS SANTOS # 201 AND AV. JORGE PEREZ CONCHA
Phone
2610680
Product use

IT IS AN IN VITRO NUCLEIC ACID AMPLIFICATION TEST FOR DETECTION QUALITATIVE TOTAL NUCLEIC ACIDS OF HUMAN IMMUNODEFICIENCY VIRUS TYPE 1 (HIV-1), IN THE GENEXPERT® SYSTEM AUTOMATED

About this record

Access comprehensive regulatory information for Xpert® HIV-1 Qual XC in the Ecuador medical device market through Pure Global AI's free database. This III medical device is registered under ARCSA ID 478fc44a0077ddc9425b4cb8c20057d1 and manufactured by CEPHEID AB. The device was registered on April 01, 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.