hema.to

Primary DI

04262375580006

Basic UDI-DI Code

B-04262375580006

Reference

1.x.y

Device Types

None provided

Regulation

Eu Ivdd

Classification

Eu Ivd General

Status

On The Market

Manufacturer

hema.to GmbH

1. Intended purpose: hema.to is a stand-alone software that supports physicians and laboratory staff in the analysis of immunophenotyping data stemming from cell suspensions of human specimens. 2. Object of Measurement: hema.to supports the diagnostician in detecting hematological malignancies using immunophenotyping data stemming from flow cytometry measurements (so-called FCS or LMD files) of cell suspensions. 3. Intended Target Population: hema.to does not impose any demographic restrictions; it is non-invasive diagnostic and screening aid using standard FC data , h 4. Medical Indications: hema.to is intended to be used with patients who are suspected of a hematological malignancy, and for whom flow cytometry is part of standard diagnostics. Indications are FC data from cell suspensions (including but not limited to blood or bone marrow). 5. Intended User: hema.to is intended to be used by personnel which have been trained to perform hematological analyses and diagnoses based on FC data. This could be either a physician and/or laboratory staff. 6. Intended Use: hema.to is used as a web application where standard flow cytometry (FC) data (FCS or LMD files) from cell suspension measurements (e.g. from blood or bone marrow) can be uploaded, to efficiently support its user in making quantified differential diagnosis and accompanying clinical reasoning. 7. Compatibilities: hema.to can only be used in combination with flow cytometers that produce standard FCS or LMD files, which are processed on their computer in their internet browser of choice. Please contact [email protected] for more information.

Other on-the-market devices with the same classification (Eu Ivd General) and regulation (EU IVDD).