CE-IVD labeling of Id-Fungi-Plates
With the arrival of Maldi-Tof as new tool in the identification of moulds and other dermatophytes, it became necessary to provide an answer to the problem of isolation and growth of these microorganisms of interest from clinical samples.
This was done with the marketing of our products.
Eager to respond favourably to the numerous requests regarding the labeling of these growing environments under DM-DIV and after many months of development.
We are proud to announce the CE-IVD labeling of IDFP and IDFP+!
Our devices are registered with THE ANSM and follow the DIRECTIVE DM-DIV 98/79/CE. The Id-Fungi Plates™ also follow NOR-101-NF EN 12322 and NOR-102- NF IN 12322-A1.
In addition to a strict specifications, with the aim of customer satisfaction (ISO 9001), the boxes provided from 25 May 2020 will be labeled CE-IVD. Responding to the requirements of the European directive and soon to the regulation that will relocate it.
We remain available to you if you wish to know more about this regulation and advise you to inform laboratory staff of these new provisions.
Our solutions associated with CE IVD labeling
IDFP
idetect
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