Pure Global
72e73b7e4ff5b4877b83f4753acea57e

ampliCube Gastrointestinal Bacterial Panel 1

MIKROGEN GMBH·III·Ecuador ARCSA·Registered June 28, 2022
Device classification
Risk class
III
Product type
In Vitro Diagnostic
Brand name
MIKROGEN
Commercial name
19-238 IVD Reagents/Kits, Molecular Assay, Infection, Bacteria
Registration information
Analysis ID
72e73b7e4ff5b4877b83f4753acea57e
Registration date
June 28, 2022
Expiration date
June 28, 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 GASTROINTESTINAL BACTERIAL PANEL 1 IS A QUALITATIVE IN VITRO TEST FOR THE SPECIFIC IDENTIFICATION OF THE DNA OF CAMPYLOBACTER (C. JEJUNI, C. COLI, C. LARI, C. FETUS, C. UPSALIENSIS), SALMONELLA SPP. AND YERSINIA ENTEROCOLITICA IN HUMAN FECAL MATERIAL TESTS.

About this record

Access comprehensive regulatory information for ampliCube Gastrointestinal Bacterial Panel 1 in the Ecuador medical device market through Pure Global AI's free database. This III medical device is registered under ARCSA ID 72e73b7e4ff5b4877b83f4753acea57e and manufactured by MIKROGEN GMBH. The device was registered on June 28, 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.