E-KH-480

Organization name

LaCAR MDx Technologies

SRN

BE-MF-000001212

Manufacturer status

Active

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

• CW999

  H360FD: May damage fertility. May damage the unborn child.
• CW073

  EUDAMED did not publish a description for this code.
• CW081

  EUDAMED did not publish a description for this code.
• CW084

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

  EUDAMED did not publish a description for this code.
• CW103

  EUDAMED did not publish a description for this code.
• CW104

  EUDAMED did not publish a description for this code.
• CW041

  EUDAMED did not publish a description for this code.
• CW044

  EUDAMED did not publish a description for this code.
• CW045

  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

05430002471945

Basic UDI-DI

B-05430002471945

Reference / catalog number

E-KH-480

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 NEONATAL Biotinidase Screening Assay is an enzymatic assay for the quantitative determination of biotinidase (BTD) activity levels. 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 a laboratory environment for biotinidase deficiency screening. The device should not be used for confirmatory testing. The kit can be used manually.

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.

• W01010199ENZYMES - OTHER