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Human Papillomavirus 23 Subtypes Genotyping Kit (PCR-reverse dot hybridization) - ARCSA Registration c8ba6433ff440981189de8a1d334acec

Access comprehensive regulatory information for Human Papillomavirus 23 Subtypes Genotyping Kit (PCR-reverse dot hybridization) in the Ecuador medical device market through Pure Global AI's free database. This III medical device is registered under ARCSA ID c8ba6433ff440981189de8a1d334acec 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
c8ba6433ff440981189de8a1d334acec
Human Papillomavirus 23 Subtypes Genotyping Kit (PCR-reverse dot hybridization)
ARCSA ID: c8ba6433ff440981189de8a1d334acec
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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
c8ba6433ff440981189de8a1d334acec
Registration Date
January 12, 2023
Expiration Date
January 12, 2028
Product Use

KIT FOR QUALITATIVE DETECTION OF HUMAN PAPILLOMAVIRUS (HPV) SUBTYPES, INCLUDING 5 LOW-RISK SUBTYPES HPV 6, 11, 42, 43, 44 AND 18, AND MEDIUM AND HIGH RISK SUBTYPES SUCH AS HPV 16, 18, 31, 33, 35, 39, 45, 51, 52, 53, 56, 58, 59, 66, 68, 73, 82, CP8304 IN URETHRAL SECRETION SAMPLES, CERVICAL EXFOLIATED CELLS AND WART CELLS.

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