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VITROS Chemistry Products Calibrator Kit 13 - ARCSA Registration 4bd9affcbc490b118fe555fec18f79af

Access comprehensive regulatory information for VITROS Chemistry Products Calibrator Kit 13 in the Ecuador medical device market through Pure Global AI's free database. This III medical device is registered under ARCSA ID 4bd9affcbc490b118fe555fec18f79af 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
4bd9affcbc490b118fe555fec18f79af
VITROS Chemistry Products Calibrator Kit 13
ARCSA ID: 4bd9affcbc490b118fe555fec18f79af
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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
4bd9affcbc490b118fe555fec18f79af
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 GENTAMICIN (GENT).

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