Pure Global

SARS-CoV-2 Antibody Test - ARCSA Registration 04b8ab36b512eaf6eeb9800fad52bb5d

Access comprehensive regulatory information for SARS-CoV-2 Antibody Test in the Ecuador medical device market through Pure Global AI's free database. This III medical device is registered under ARCSA ID 04b8ab36b512eaf6eeb9800fad52bb5d and manufactured by BEIJING LEPU MEDICAL TECHNOLOGY CO. LTD.. The device was registered on May 21, 2020.

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.

Free Database
Powered by Pure Global AI
ARCSA Official Data
III
04b8ab36b512eaf6eeb9800fad52bb5d
SARS-CoV-2 Antibody Test
ARCSA ID: 04b8ab36b512eaf6eeb9800fad52bb5d
Pure Global
DJ Fang

DJ Fang

MedTech Regulatory Expert

Need help with 30+ markets registration?

Pricing
Device Classification
Risk Class
III
Product Type
In Vitro Diagnostic
Brand Name
MADISON
Commercial Name
22-339 REAGENTS/KITS FOR DIV ASSAYS, MOLECULAR ASSAY, INFECTION, SEVERE ACUTE RESPIRATORY SYNDROME CORONAVIRUS VIRUS, RNA
Registration Information
Analysis ID
04b8ab36b512eaf6eeb9800fad52bb5d
Registration Date
May 21, 2020
Expiration Date
May 21, 2025
Product Use

USED FOR QUALITATIVE DETECTION OF SARS COV-2 ANTIBODY CONTENT IN CLINICAL SAMPLES SUCH AS SERUM, PLASMA AND WHOLE BLOOD

Manufacturer
Country
CHINA
Address
BUILDING 7-1 NO 37 CHAOQUIAN ROAD, CHANGPING DISTRICT, BEIJING 102200, PR, CHINA
Product Owner
Name
MADISON ORTHO INC
Country
PUERTO RICO
Authorized Representative
Address
AV CATALINA ALDAZ N34-155 AND PORTUGAL. CATALINA PLAZA BUILDING
Phone
2520070