Pure Global
88fdec6e1f40f52cd582f297d0b74c4e

iStar-CA19-9

SHENZHEN YHLO BIOTECH CO., LTD.·III·Ecuador ARCSA·Registered March 31, 2023
Device classification
Risk class
III
Product type
In Vitro Diagnostic
Brand name
DRAWRAY
Commercial name
19-096 IVD Reagents/Kits, Immunoassay, Tumor Marker
Registration information
Analysis ID
88fdec6e1f40f52cd582f297d0b74c4e
Registration date
March 31, 2023
Expiration date
March 31, 2028
Manufacturer
Name
SHENZHEN YHLO BIOTECH CO., LTD.
City
SHENZHEN
Country
CHINA
Address
BUILDING 1, YHLO BIOPARK, BAOLONG 2ND ROAD, BAOLONG SUBDISTRICT, LONGGANG DISTRICT 518116 SHENZHEN, PLEOPLE'S REPUBLIC OF CHINA
Product owner
Name
SHENZHEN DRAWRAY BIOTECH CO., LTD
Country
CHINA
Authorized representative
Name
FRISONEX FRISON IMPORTADORA EXPORTADORA CIA. LTDA.
Address
LAS AVELLANAS STREET E2-25 AND JUNCAL
Phone
23971600
Product use

QUANTITATIVE DETERMINATION OF CARBOHDRATE 19-9 (CA19-9) ANTIGEN IN HUMAN SERUM AND PLASMA USING THE ISTAR IMMUNOASSAY ANALYZER.

About this record

Access comprehensive regulatory information for iStar-CA19-9 in the Ecuador medical device market through Pure Global AI's free database. This III medical device is registered under ARCSA ID 88fdec6e1f40f52cd582f297d0b74c4e and manufactured by SHENZHEN YHLO BIOTECH CO., LTD.. The device was registered on March 31, 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.