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RaFIA TSH FIA Test - ARCSA Registration 7aabdfcb722abd3b58d6f25b09783fe7

Access comprehensive regulatory information for RaFIA TSH FIA Test in the Ecuador medical device market through Pure Global AI's free database. This II medical device is registered under ARCSA ID 7aabdfcb722abd3b58d6f25b09783fe7 and manufactured by CTK BIOTECH, INC. The device was registered on March 11, 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
II
7aabdfcb722abd3b58d6f25b09783fe7
RaFIA TSH FIA Test
ARCSA ID: 7aabdfcb722abd3b58d6f25b09783fe7
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Device Classification
Risk Class
II
Product Type
In Vitro Diagnostic
Brand Name
CTK Biotech®
Commercial Name
19-199- Reagents/Kits for IVD Assays, Immunoassay, Standard.
Registration Information
Analysis ID
7aabdfcb722abd3b58d6f25b09783fe7
Registration Date
March 11, 2022
Expiration Date
March 11, 2027
Product Use

FOR IN VITRO DIAGNOSIS: THE THYROXINE (TSH) THYROXINE (T4) AND TRIIODOTHYRONINE (T3) FLUORESCENCE IMMUNOASSAY (FIA) TEST IS A FLUORESCENCE CHROMATOGRAPHIC IMMUNOASSAY LATERAL FLOW TEST FOR THE QUANTITATIVE DETECTION OF TSH IN HUMAN SERUM, PLASMA OR BLOOD,

Manufacturer
City
POWAY
Country
UNITED STATES
Address
13855 STOWE DRIVE
Product Owner
Name
CTK BIOTECH, INC
Country
UNITED STATES
Authorized Representative
Address
URDESA CENTRAL AV. VICTOR EMILIO ESTRADA 917 BETWEEN HIGUERAS AND ILANES
Phone
2881414