I-ME-576

Organization name

Zentech s.a.

SRN

BE-MF-000001650

Manufacturer status

Active

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

• CW074

  EUDAMED did not publish a description for this code.
• CW078

  EUDAMED did not publish a description for this code.
• CW086

  EUDAMED did not publish a description for this code.
• CW999

  H379: May cause damage to organs (brain) through prolonged or repeated exposure if swallowed
• 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

05425025461127

Basic UDI-DI

B-05425025461127

Reference / catalog number

I-ME-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 G-6-PD Screening Fluo is an enzymatic assay for the quantitative determination of G-6-PD activity. The device has been designed for neonate’s samples1 using dried blood spot samples dried on 903® or 226 filter paper2. This device is used by health professionals in a laboratory environment for G-6-PD deficiency screening. The kit should not be used for confirmatory testing or to monitor therapy. 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