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HIV 1/2/O Tri-line Human Immunodeficiency Virus Rapid Test Device Ref-IHI-T402 - ARCSA Registration 36206d924a1039e60249581f3b542224

Access comprehensive regulatory information for HIV 1/2/O Tri-line Human Immunodeficiency Virus Rapid Test Device Ref-IHI-T402 in the Ecuador medical device market through Pure Global AI's free database. This III medical device is registered under ARCSA ID 36206d924a1039e60249581f3b542224 and manufactured by ABON BIOPHARM (HANGZHOU) CO., LTD. The device was registered on August 27, 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
36206d924a1039e60249581f3b542224
HIV 1/2/O Tri-line Human Immunodeficiency Virus Rapid Test Device Ref-IHI-T402
ARCSA ID: 36206d924a1039e60249581f3b542224
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Device Classification
Risk Class
III
Product Type
In Vitro Diagnostic
Brand Name
SHREDDED
Commercial Name
19-084 IVD Reagents/Kits, Serology, Rapid Assay, Virus
Registration Information
Analysis ID
36206d924a1039e60249581f3b542224
Registration Date
August 27, 2023
Expiration Date
August 27, 2028
Product Use

IT IS A RAPID CHROMATOGRAPHIC IMMUNOASSAY FOR THE QUALITATIVE DETECTION OF ANTIBODIES TO HIV-1, HIV-2, AND SUBTYPE O IN WHOLE BLOOD, SERUM, OR PLASMA AS AN AID IN THE DIAGNOSIS OF HIV INFECTION.

Manufacturer
City
HANGZHOU
Country
CHINA
Address
198 12TH STREET EAST, HANGZHOU ECONOMIC & TECHNOLOGICAL DEVELOPMENT AREA, HANGZHOU, 310018, P.R. CHINA
Product Owner
Name
ABON BIOPHARM (HANGZHOU) CO., LTD
Country
CHINA
Authorized Representative
Address
AV. REPUBLICA DEL SALVADOR N34-493 AND PORTUGAL GIBRALTAR BUILDING 10TH FLOOR
Phone
980670023