Pure Global
826e1f5f19014c0934f382492cb76587

ampliCube Respiratory Viral Panel 2

MIKROGEN GMBH·III·Ecuador ARCSA·Registered June 30, 2022
Device classification
Risk class
III
Product type
In Vitro Diagnostic
Brand name
MIKROGEN
Commercial name
19-242 IVD Reagents/Kits, Molecular Assay, Infection, Viruses
Registration information
Analysis ID
826e1f5f19014c0934f382492cb76587
Registration date
June 30, 2022
Expiration date
June 30, 2027
Manufacturer
Name
MIKROGEN GMBH
City
NEURIED
Country
GERMANY
Address
FLORIANSBOGEN 2-4, 82061 NEURIED, GERMANY
Product owner
Name
MIKROGEN GMBH
Country
GERMANY
Authorized representative
Name
SIGMA HEALTH DEL ECUADOR SIGMAHEALTH CIA. LTDA.
Address
AV. EUGENIO ESPEJO 2410 VIA A TANDA NAYON, PLAZA DEL RANCHO
Phone
987070898
Product use

THE AMPLICUBE RESPIRATORY VIRAL PANEL 2 IS A QUALITATIVE IN VITRO TEST USED TO SPECIFICALLY IDENTIFY RNA OF PARAINFLUENZA VIRUSES (1-4) AND DNA OF HUMAN BOCAVIRUSES IN HUMAN SPUTUM, SMEAR, BAL (BRONCHOALVEOLAR LAVAGE) OR HUMAN TRACHEAL SECRETION.

About this record

Access comprehensive regulatory information for ampliCube Respiratory Viral Panel 2 in the Ecuador medical device market through Pure Global AI's free database. This III medical device is registered under ARCSA ID 826e1f5f19014c0934f382492cb76587 and manufactured by MIKROGEN GMBH. The device was registered on June 30, 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.