J-LS-96PartA

Organization name

LaCAR MDx Technologies

SRN

BE-MF-000001212

Manufacturer status

Active

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

• CW089

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• CW085

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• CW082

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• CW076

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• CW057

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• CW088

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• CW080

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• CW043

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• CW038

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Primary placement in Belgium; available across 1 country total.

Trade name

not provided

UDI-DI code

05430003908013

Basic UDI-DI

B-05430003908013

Reference / catalog number

J-LS-96PartA

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 Targeted MS/MS Hemo screening assay is a qualitative sample processing assay for the detection of trypsin digested peptides from normal and variant haemoglobins (HbA, HbA2, HbF, HbS, HbC, HbE, HbOArab, HbDPunjab). This device has been designed for neonates’ samples1, using dried blood spot on 903® or 226 filter paper2. This device is used by health professionals in laboratory environment for haemoglobinopathies screening, e.g. α-thalassaemias, β-thalassaemias and sickle cell disease. It also enables to detect the compounds heterozygous patients and the healthy carriers of one globin variant (e.g. HbSC or HbAS).

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.

• W0103010202HAEMOGLOBIN SUBTYPES HBA2, HBC, HBF, HBS, ETC.(EXCL. HBA1)