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Human Papillomavirus 16 & 18 Nucleic Acid Detection Kit (PCR-Fluorescent Probing) - ARCSA Registration 7c7c72b3656fde9e1a2dcf0d17296d02

Access comprehensive regulatory information for Human Papillomavirus 16 & 18 Nucleic Acid Detection Kit (PCR-Fluorescent Probing) in the Ecuador medical device market through Pure Global AI's free database. This III medical device is registered under ARCSA ID 7c7c72b3656fde9e1a2dcf0d17296d02 and manufactured by TRIPLEX INTERNATIONAL BIOSCIENCES (CHINA) CO., LTD.. The device was registered on January 12, 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.

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ARCSA Official Data
III
7c7c72b3656fde9e1a2dcf0d17296d02
Human Papillomavirus 16 & 18 Nucleic Acid Detection Kit (PCR-Fluorescent Probing)
ARCSA ID: 7c7c72b3656fde9e1a2dcf0d17296d02
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Device Classification
Risk Class
III
Product Type
In Vitro Diagnostic
Brand Name
TIB
Commercial Name
19-249 IVD Reagents/Kits, Molecular Assay, Infection, Virus, Human Papillomavirus
Registration Information
Analysis ID
7c7c72b3656fde9e1a2dcf0d17296d02
Registration Date
January 12, 2023
Expiration Date
January 12, 2028
Product Use

KIT FOR THE QUALITATIVE IN VITRO DETECTION OF SUBTYPES 16 AND 18 OF THE HUMAN PAPILLOMAVIRUS HPV IN FEMALE CERVICAL SAMPLES.

Manufacturer
City
XIAMEN
Country
CHINA
Address
UNIT 101, 201, AND 301, NO. 2041, UNIT 101, 201, AND 501, NO. 2045, XIZHOU ROAD, TONGAN DISTRICT, 361100 XIAMEN, PEOPLE'S REPUBLIC OF CHINA
Product Owner
Name
TRIPLEX INTERNATIONAL BIOSCIENCES (CHINA) CO., LTD.
Country
CHINA
Authorized Representative
Address
CALLE PARAISO NUMERO OE 5-468 Y EL EDEN
Phone
23430753