I-MD-576

Organization name

LaCAR MDx Technologies

SRN

BE-MF-000001212

Manufacturer status

Active

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Primary placement in Belgium; available across 1 country total.

Trade name

not provided

UDI-DI code

05430003908068

Basic UDI-DI

B-05430003908068

Reference / catalog number

I-MD-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 MSUD Screening Fluo is an enzymatic assay for the quantitative determination of Branched Chain Amino Acids (BCAAs) 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 Maple Syrup Urine Disease (MSUD) screening. The device should not be used for confirmatory testing. The device is intended to 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