Eu Ivdd Eu Ivd General On The Market 🇨🇳 China

28 Types of Human Papillomavirus (16/18 Typing) Nucleic Acid Detection Kit (Fluorescence PCR)

Devices (same UDI-DI)
1
Certificates
0
Countries
0
Notified Bodies
0

Basic Information

Primary DI
D-0000128071480ABRZ
Basic UDI-DI Code
B-0000128071480ABRZ
Reference
HWTS-CC006
Device Types
None provided
Regulation
Eu Ivdd
Classification
Eu Ivd General
Status
On The Market

Additional Description

This kit is suitable for in vitro qualitative detection of 28 types of human papillomavirus (HPV 6, 11, 16, 18, 26, 31, 33, 35, 39, 40, 42, 43, 44, 45, 51, 52, 53, 54, 56, 58, 59, 61, 66, 68, 73, 81, 82, 83) nucleic acids in clinical urine sample, female cervical swab sample and female vaginal swab sample, as well as HPV 16/18 typing detection, while the remaining types cannot be completely distinguished, providing an aid in the diagnosis and treatment of HPV infection.

CND Nomenclature Codes

Code Description
W0105041003 PARTIAL GENOTYPING HIGH-RISK HPV - NA REAGENTS
W010699 GENETIC TESTS - OTHER

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