E-IZ-576

Organization name

Zentech s.a.

SRN

BE-MF-000001650

Manufacturer status

Active

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

• CW041

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

  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.

Primary placement in Belgium; available across 1 country total.

Trade name

not provided

UDI-DI code

05425025460656

Basic UDI-DI

B-05425025460656

Reference / catalog number

E-IZ-576

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 Total Galactose Screening Assay is an enzymatic assay for the quantitative determination of total galactose (T-GAL). This device has been designed for neonates’ samples1, using blood spot dried on 903® or 226 filter paper2. This device is used by health professionals in a laboratory environment for galactosemia screening. The device should not be used for confirmatory testing. The kit can be used manually or with an automate.

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