NF-light ELISA

Organization name

UmanDiagnostics 5566982418

SRN

SE-MF-000031407

Manufacturer status

Active

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

• CW082

  The stop reagent contains diluted sulphuric acid
• CW085

  The stop reagent contains diluted sulphuric acid
• CW043

  The stop reagent contains diluted sulphuric acid
• CW032

  Do not use past expiration date.
• CW009

  EUDAMED did not publish a description for this code.
• CW007

  EUDAMED did not publish a description for this code.
• CW167

  EUDAMED did not publish a description for this code.
• CW132

  EUDAMED did not publish a description for this code.
• CW267

  The standard preparation contains bovine NF-L.

Primary placement in Sweden; available across 32 countries total.

Trade name

NF-light ELISA

UDI-DI code

D-SE-MF-0000314075B

Basic UDI-DI

B-SE-MF-0000314075B

Reference / catalog number

10-7001

Issuing entity

EUDAMED

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

Enzyme Linked Immunosorbent Assay for measurement of Neurofilament Light (NF-L) in Cerebrospinal Fluid (CSF).

Additional information URL

https://www.umandiagnostics.se/cms/support/

Clinical sizes

No clinical sizes registered for this device.

• Batch number
• Expiration date
• Manufacturing date
• Serial number
• Software identification

D-SE-MF-0000314075B

DataMatrix generation currently supports GS1-issued UDIs. HIBCC / ICCBBA support is coming.

European Medical Device Nomenclature — the EU product classification assigned to this device.

• W0102019099SPECIFIC PROTEINS - OTHER

This device is not currently linked to any other device.