LC-HFE-LP-96

Organization name

LaCAR MDx Technologies

SRN

BE-MF-000001212

Manufacturer status

Active

3 warnings recorded — scroll inside the panel to see all entries.

• CW082

  EUDAMED did not publish a description for this code.
• CW085

  EUDAMED did not publish a description for this code.
• CW043

  EUDAMED did not publish a description for this code.

Primary placement in Belgium; available across 1 country total.

Trade name

not provided

UDI-DI code

05430002471075

Basic UDI-DI

B-05430002471075

Reference / catalog number

LC-HFE-LP-96

Issuing entity

GS1

Risk category

IVDD — General

Applicable legislation

IVDD [Directive 98/79/EC on in vitro diagnostic medical devices]

Status

On the market

Quantity

1

Additional product description

The LAMP Human Hemochromatosis KIT (rs1800562/rs1799945) is an in vitro diagnostic test intended for the qualitative detection of the C282Y and H63D mutations by Loop mediated isothermal amplification (LAMP) on EDTA anticoagulated whole blood and extracted DNA samples. This test is intended to as an aid to the diagnosis of hemochromatosis mutations C282Y and H63D. This assay is dedicated to professional use in diagnostic laboratory. The device is not for self testing. [

Additional information URL

https://www.lacar-mdx.com/

Clinical sizes

No clinical sizes registered for this device.

• Batch number
• Expiration date
• Manufacturing date
• Serial number
• Software identification

European Medical Device Nomenclature — the EU product classification assigned to this device.

• W0106010105HAEMOCHROMATOSIS