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VITROS Chemistry Products GENT Reagent - ARCSA Registration a9047a3a23aaee8c793914449dce439e

Access comprehensive regulatory information for VITROS Chemistry Products GENT Reagent in the Ecuador medical device market through Pure Global AI's free database. This III medical device is registered under ARCSA ID a9047a3a23aaee8c793914449dce439e and manufactured by ORTHO CLINICAL DIAGNOSTICS INC. The device was registered on May 18, 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.

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III
a9047a3a23aaee8c793914449dce439e
VITROS Chemistry Products GENT Reagent
ARCSA ID: a9047a3a23aaee8c793914449dce439e
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Device Classification
Risk Class
III
Product Type
In Vitro Diagnostic
Brand Name
VITREOUS
Commercial Name
17-091 DIV ASSAY REAGENTS/KITS, CLINICAL CHEMISTRY
Sterilization Method
ENZYMATIC BIOCHEMICAL METHODOLOGY
Registration Information
Analysis ID
a9047a3a23aaee8c793914449dce439e
Registration Date
May 18, 2022
Expiration Date
May 18, 2027
Creation Date
May 18, 2022
Product Use

IT IS USED TO QUANTITATIVELY DETERMINE THE CONCENTRATION OF GENTAMICIN (GENT) IN HUMAN SERUM AND PLASMA

Manufacturer
City
ROCHESTER NEW YORK
Country
UNITED STATES
Address
1000 LEE READ
Product Owner
Name
ORTHO CLINICAL DIAGNOSTICS INC
Country
UNITED KINGDOM OF GREAT BRITAIN
Authorized Representative
Address
EL ARENAL STREET OE11-192 AND PANAMERICANA NORTE
Phone
23477164