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VITROS Chemistry Products Calibrator Kit 11 - ARCSA Registration 0df288793878bc4f4151f30b39b7337a

Access comprehensive regulatory information for VITROS Chemistry Products Calibrator Kit 11 in the Ecuador medical device market through Pure Global AI's free database. This III medical device is registered under ARCSA ID 0df288793878bc4f4151f30b39b7337a 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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ARCSA Official Data
III
0df288793878bc4f4151f30b39b7337a
VITROS Chemistry Products Calibrator Kit 11
ARCSA ID: 0df288793878bc4f4151f30b39b7337a
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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
0df288793878bc4f4151f30b39b7337a
Registration Date
May 18, 2022
Expiration Date
May 18, 2027
Creation Date
May 18, 2022
Product Use

IT IS USED IN THE CALIBRATION OF VITRO ANALYZERS IN ORDER TO MEASURE QUANTITATIVELY VANCOMYCIN (VANC).

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