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641ff3174a18dadb1a09aef3370dbabd

RaFIA HbA1c FIA Test

CTK BIOTECH, INC·II·Ecuador ARCSA·Registered February 11, 2022
Device classification
Risk class
II
Product type
In Vitro Diagnostic
Brand name
CTK Biotech®
Commercial name
19-712 IVD Reagents/Assay Kits, Immunoassay, Diabetes, Glycosylated Hemoglobin
Registration information
Analysis ID
641ff3174a18dadb1a09aef3370dbabd
Registration date
February 11, 2022
Expiration date
February 11, 2027
Manufacturer
Name
CTK BIOTECH, INC
City
POWAY
Country
UNITED STATES
Address
13855 STOWE DRIVE
Product owner
Name
CTK BIOTECH, INC
Country
UNITED STATES
Authorized representative
Name
MEDIBAC-INC S.A.S.
Address
URDESA CENTRAL AV. VICTOR EMILIO ESTRADA 917 BETWEEN HIGUERAS AND ILANES
Phone
2881414
Product use

FOR IN VITRO DIAGNOSIS: THE HBA1C FLUORESCENCE IMMUNOASSAY (FIA) TEST IS A FLUORESCENCE CHROMATOGRAPHIC IMMUNOASSAY LATERAL FLOW TEST FOR THE QUANTITATIVE DETECTION OF HBA1C IN HUMAN SERUM, PLASMA OR BLOOD.

About this record

Access comprehensive regulatory information for RaFIA HbA1c FIA Test in the Ecuador medical device market through Pure Global AI's free database. This II medical device is registered under ARCSA ID 641ff3174a18dadb1a09aef3370dbabd and manufactured by CTK BIOTECH, INC. The device was registered on February 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.