KROMA Plus iT Automatic Immunological Analyzer

Organization name

Linear Chemicals S.L.U

SRN

ES-MF-000003284

Manufacturer status

Active

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

• CW011

  Warning of Moving Parts. Generic Danger Icon: This icon is placed on the sampling probe protection defence of the instrument and on the protection of the washing station of the reading cuvettes. It informs the user of the potential risk caused by moving mechanic parts when the protection defence is opened or the washing station protection is removed.
• CW259

  Electrical Risk Danger Icon. This icon, placed on the AC/DC power supply area and on the back of the instrument, near the main switch, informs the user of the electrical risk.

Primary placement in Spain; available across 1 country total.

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

Trade name

KROMA Plus iT Automatic Immunological Analyzer

UDI-DI code

8435287393309

Basic UDI-DI

843528739330HT

Reference / catalog number

3800070

Issuing entity

HIBCC

Risk category

IVDR Class A

Applicable legislation

IVDR [Regulation (EU) 2017/746 on in vitro diagnostic medical devices]

Status

On the market

Quantity

1

Additional product description

KROMA Plus iT Automatic Immunological Analyzer

Additional information URL

No additional information URL provided by the manufacturer.

Clinical sizes

No clinical sizes registered for this device.

• W0201020101AUTOMATED IMMUNOCHEMISTRY ANALYSERS - LOW ROUTINE (Throughput <= 100 test/h)

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