72500334

Organization name

Labsystems Diagnostics Oy

SRN

FI-MF-000018281

Manufacturer status

Active

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

• CW010

  EUDAMED did not publish a description for this code.
• CW008

  EUDAMED did not publish a description for this code.
• CW263

  EUDAMED did not publish a description for this code.
• CW032

  EUDAMED did not publish a description for this code.

Primary placement in Finland; available across 1 country total.

Placed on the market in Finland; per-country availability dates not published.

Trade name

not provided

UDI-DI code

06438172404052

Basic UDI-DI

B-06438172404052

Reference / catalog number

72500334

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

VAE-Control set (Low) is intended to be used in clinical laboratories for the quantitative determination of vitamin A and E in serum and plasma to detect deficiencies or hypervitaminosis. Vitamin A and E Serum Controls are used for quality assurance in determining the accuracy of analytes Vitamin A and Vitamin E in Serum or Plasma. The Serum Controls are prepared by using Pooled Human Serum and are used in the same way as patient samples. It is recommended to use controls in duplicates at each level per run.

Additional information URL

No additional information URL provided by the manufacturer.

Clinical sizes

No clinical sizes registered for this device.

• W0102152006ANAEMIA RELATED/VITAMIN CONTROLS

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