42c425698b5c22a03ff9a1acbd3a33b9

iStar-Anti-Tg

SHENZHEN YHLO BIOTECH CO., LTD.·II·Ecuador ARCSA·Registered March 21, 2023

Device classification

Risk class: II
Product type: In Vitro Diagnostic
Brand name: DRAWRAY
Commercial name: 19-108 IVD Reagents/Assay Kits, Immunoassay, Thyroid Hormone

Registration information

Analysis ID: 42c425698b5c22a03ff9a1acbd3a33b9
Registration date: March 21, 2023
Expiration date: March 21, 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 THYROGLOBULIN (TG) ANTIBODIES IN HUMAN SERUM AND PLASMA USING THE ISTAR IMMUNOASSAY ANALYZER.

About this record

Access comprehensive regulatory information for iStar-Anti-Tg in the Ecuador medical device market through Pure Global AI's free database. This II medical device is registered under ARCSA ID 42c425698b5c22a03ff9a1acbd3a33b9 and manufactured by SHENZHEN YHLO BIOTECH CO., LTD.. The device was registered on March 21, 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.