Pure Global

VITROS Chemistry Products TOBRA Reagent - ARCSA Registration 58988e8708ac38d6ca8630e69a9053e7

Access comprehensive regulatory information for VITROS Chemistry Products TOBRA Reagent in the Ecuador medical device market through Pure Global AI's free database. This III medical device is registered under ARCSA ID 58988e8708ac38d6ca8630e69a9053e7 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.

Free Database
Powered by Pure Global AI
ARCSA Official Data
III
58988e8708ac38d6ca8630e69a9053e7
VITROS Chemistry Products TOBRA Reagent
ARCSA ID: 58988e8708ac38d6ca8630e69a9053e7
Pure Global
DJ Fang

DJ Fang

MedTech Regulatory Expert

Need help with 30+ markets registration?

Pricing
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
58988e8708ac38d6ca8630e69a9053e7
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 TOBRAMYCIN (TOBRA) 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