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cobas HEV Control Kit - ARCSA Registration 6a78fa62186e65c8e08a5b20f23d4ff2

Access comprehensive regulatory information for cobas HEV Control Kit in the Ecuador medical device market through Pure Global AI's free database. This III medical device is registered under ARCSA ID 6a78fa62186e65c8e08a5b20f23d4ff2 and manufactured by ROCHE MOLECULAR SYSTEMS INC.. The device was registered on November 27, 2023.

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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III
6a78fa62186e65c8e08a5b20f23d4ff2
cobas HEV Control Kit
ARCSA ID: 6a78fa62186e65c8e08a5b20f23d4ff2
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Device Classification
Risk Class
III
Product Type
In Vitro Diagnostic
Brand Name
ROCHE
Commercial Name
19-242 IVD Reagents/Kits, Molecular Assay, Infection, Viruses
Registration Information
Analysis ID
6a78fa62186e65c8e08a5b20f23d4ff2
Registration Date
November 27, 2023
Expiration Date
November 27, 2028
Product Use

QUALITATIVE IN VITRO NUCLEIC ACID AMPLIFICATION TEST FOR THE DIRECT DETECTION OF HEPATITIS E VIRUS (HEV) RNA (GENOTYPES 1-4) IN HUMAN PLASMA

Manufacturer
City
BRANCHBURG
Country
UNITED STATES
Address
1080 US HIGHWAY 202 SOUTH, BRANCHBURG NEW JERSEY, 08876
Product Owner
Name
ROCHE DIAGNOSTICS GMBH
Country
GERMANY
Authorized Representative
Address
AV SIMON BOLIVAR N/A Y VIA A NAYON
Phone
3997100