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One Step Anti-HIV (1&2) Tri-Line Test - ARCSA Registration 9eac66c426f0c45653cb854b64a44951

Access comprehensive regulatory information for One Step Anti-HIV (1&2) Tri-Line Test in the Ecuador medical device market through Pure Global AI's free database. This III medical device is registered under ARCSA ID 9eac66c426f0c45653cb854b64a44951 and manufactured by INTEC PRODUCTS, INC.. The device was registered on November 22, 2023.

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
9eac66c426f0c45653cb854b64a44951
One Step Anti-HIV (1&2) Tri-Line Test
ARCSA ID: 9eac66c426f0c45653cb854b64a44951
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Device Classification
Risk Class
III
Product Type
In Vitro Diagnostic
Brand Name
INTEC, ADVANCE QUALITY
Commercial Name
19-478 IVD Reagents/Assay Kits, Serology, Rapid Assay, Virus, Retrovirus, HIV-1/2
Registration Information
Analysis ID
9eac66c426f0c45653cb854b64a44951
Registration Date
November 22, 2023
Expiration Date
November 22, 2028
Product Use

DETECTION OF HUMAN IMMUNODEFICIENCY VIRUS (HIV) ANTIBODIES IN HUMAN WHOLE BLOOD, SERUM, OR PLASMA SAMPLES

Manufacturer
City
XIAMEN
Country
CHINA
Address
332 XINGUANG ROAD, XINYANG INDUSTRIAL AREA, HAICANG, XIAMEN, 361022, FUJIAN, P. R. CHINA
Product Owner
Name
INTEC PRODUCTS, INC.
Country
CHINA
Authorized Representative
Address
CALLE 7MO CALLEJON 18E NO S/N Y 6TO PASAJE 38B
Phone
43083590