J-LS-480PartA

Organization name

Zentech s.a.

SRN

BE-MF-000001650

Manufacturer status

Active

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

• CW089

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

  EUDAMED did not publish a description for this code.
• CW082

  EUDAMED did not publish a description for this code.
• CW090

  EUDAMED did not publish a description for this code.
• CW076

  EUDAMED did not publish a description for this code.
• CW080

  EUDAMED did not publish a description for this code.
• CW088

  EUDAMED did not publish a description for this code.
• CW057

  EUDAMED did not publish a description for this code.
• CW038

  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

05425025460007

Basic UDI-DI

B-05425025460007

Reference / catalog number

J-LS-480PartA

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)