1dcf805372a06722a01b1edfee9fb91c

High Risk HPV DNA Test (PCR Fluorescent Probe Method)

GUANGZHOU HEAS BIOTECH CO., LTD.·III·Ecuador ARCSA·Registered June 29, 2023
Device classification
Risk class
III
Product type
In Vitro Diagnostic
Brand name
GOOD BIOTECH
Commercial name
22-306 IVD Reagents/Kits, Molecular Assay, Infection, Virus, Human Papillomavirus, High Risk Types, DNA
Registration information
Analysis ID
1dcf805372a06722a01b1edfee9fb91c
Registration date
June 29, 2023
Expiration date
June 29, 2028
Manufacturer
City
GUANGZHOU
Country
CHINA
Address
UNIT B, 4TH FLOOR, A8 BUILDING, NO.11 KAIYUAN ROAD, SCIENCE CITY, HIGH-TECH INDUSTRIAL DEVELOPMENT DISTRICT GUANGZHOU CITY
Product owner
Name
GUANGZHOU HEAS BIOTECH CO., LTD.
Country
CHINA
Authorized representative
Address
LAS AVELLANAS STREET E2-25 AND JUNCAL
Phone
23971600
Product use

QUALITATIVE DETECTION OF HIGH-RISK HPV GENOTYPES (16, 18, 26, 31, 33, 35, 39, 45, 51, 52, 53, 56, 58, 59, 66, 68, 73, 82) IN EXFOLIATED CERVICAL CELL SAMPLES AND GENITOURINARY TRACT SECRETIONS. IN ADDITION, IT SPECIFICALLY DETECTS AND DISTINGUISHES TYPE 16 HPV AND TYPE 18 HPV BOTH OF WHICH HAVE A HIGHER INCIDENCE RATE.

About this record

Access comprehensive regulatory information for High Risk HPV DNA Test (PCR Fluorescent Probe Method) in the Ecuador medical device market through Pure Global AI's free database. This III medical device is registered under ARCSA ID 1dcf805372a06722a01b1edfee9fb91c and manufactured by GUANGZHOU HEAS BIOTECH CO., LTD.. The device was registered on June 29, 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.