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Syphilis Ultra Rapid Test Strip (Whole Blood/Serum/Plasma) Ref-ISY-U401 - ARCSA Registration 4723d1d2a57f3de2c6d5cbf719e740df

Access comprehensive regulatory information for Syphilis Ultra Rapid Test Strip (Whole Blood/Serum/Plasma) Ref-ISY-U401 in the Ecuador medical device market through Pure Global AI's free database. This III medical device is registered under ARCSA ID 4723d1d2a57f3de2c6d5cbf719e740df and manufactured by ABON BIOPHARM (HANGZHOU) CO., LTD. The device was registered on December 20, 2021.

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
4723d1d2a57f3de2c6d5cbf719e740df
Syphilis Ultra Rapid Test Strip (Whole Blood/Serum/Plasma) Ref-ISY-U401
ARCSA ID: 4723d1d2a57f3de2c6d5cbf719e740df
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Pricing
Device Classification
Risk Class
III
Product Type
In Vitro Diagnostic
Brand Name
SHREDDED
Commercial Name
19-471 IVD Reagents/Kits, Serology, Rapid Assay, Bacteria, Syphilis
Sterilization Method
ANALYTICAL METHODOLOGY: SEPARATION. CHROMATOGRAPHY
Registration Information
Analysis ID
4723d1d2a57f3de2c6d5cbf719e740df
Registration Date
December 20, 2021
Expiration Date
December 20, 2026
Creation Date
May 10, 2022
Product Use

ULTRA RAPID SYPHILIS STRIP TEST (WHOLE BLOOD/SERUM/PLASMA) IS A RAPID CHROMATOGRAPHIC IMMUNOASSAY FOR THE QUALITATIVE DETECTION OF ANTIBODIES (IGG AND IGM) TO TREPONEMA PALLIDUM (TP) IN WHOLE BLOOD, SERUM OR PLASMA TO AID IN THE DIAGNOSIS OF SYPHILIS.

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