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Candida albicans /Gardnerella vaginalis/Trichomonas vaginalis antigen Combo Rapid Test

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

Basic Information

Primary DI
16972698604123
Basic UDI-DI Code
B-16972698604123
Reference
P271102
Device Types
Single use
Regulation
Eu Ivdd
Classification
Eu Ivd General
Status
On The Market

Additional Description

The Candida albicans/ Gardnerella vaginalis/Trichomonas vaginalis antigen Combo Rapid Test is a lateral flow chromatographic immunoassay for the qualitative detection of Candida albicans/Trichomonas vaginalis /Gardnerella vaginalis antigens from vaginalswabs. It is intended to be used as a screening test and as an aid in the diagnosis of infection with Candida albicans, Trichomonas vaginalis and Gardnerella vaginalis. Any reactive specimen with the Candida albicans/Gardnerella vaginalis/Trichomonas vaginalis antigen Combo Rapid Test must be confirmed with alternative testing method(s) and clinical findings.(20 tests/kit)

CND Nomenclature Codes

Code Description
W0105070599 MULTIPLE INFECTIOUS - MULTIPLEX ASSAYS - OTHER

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