Organization name

Mercodia AB

SRN

SE-MF-000005175

Manufacturer status

Active

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

• P310 Immediatly call poison center/doctor

  OTHER

• Do not re-use

  Each well can only be used once.

• Contains biological material of human origin

  Warning! This kit contains reagents that may be infectious! This kit contains reagents manufactured from human blood components. The source of material have been tested by immunoassay for Hepatitis B surface antigen, antibodies for Hepatitis C virus and for antibodies for HIV virus and found to be negative. Nevertheless, all recommended precautions for the handling of blood derivatives should be observed. Please refer to HHS Publication No. (CDC) 88-8395 or corresponding local/national guidelines on laboratory safety procedures.

• H317 – May cause an allergic skin reaction.
• H332 – Harmful if inhaled.
• H412 – Harmful to aquatic life with long lasting effects.
• P261 – Avoid breathing dust/fume/gas/mist/vapours/spray.
• P271 – Use only outdoors or in a well-ventilated area.
• P273 – Avoid release to the environment.
• P309 – IF exposed or if you feel unwell: P312 – Call a POISON CENTER or doctor/physician if you feel unwell.
• P304 – IF INHALED: P340 – Remove victim to fresh air and keep at rest in a position comfortable for breathing.
• P101 – If medical advice is needed, have product container or label at hand.
• P333 – If skin irritation or rash occurs: P313 – Get medical advice/attention.
• P272 – Contaminated work clothing should not be allowed out of the workplace.
• P501.1 Dispose of contents/container to dispose of contents/container in accordance with local/regional/national/international regulations.

  OTHER

• H315 – Causes skin irritation.
• H318 – Causes serious eye damage.
• P264 – Wash thoroughly after handling.
• P280 – Wear protective gloves/protective clothing/eye protection/face protection.
• P332 – If skin irritation occurs: P313 – Get medical advice/attention.
• P302 – IF ON SKIN: P352 – Wash with plenty of soap and water.
• P305 – IF IN EYES: P338 – Remove contact lenses, if present and easy to do. Continue rinsing.
• P305 – IF IN EYES: P351 – Rinse cautiously with water for several minutes.
• P364 And wash it before reuse.

  P362 Take off contaminated clothing

Primary placement in Sweden; available across 32 countries total.

Trade name

Mercodia Oxidized LDL ELISA

UDI-DI code

Primary DI

The Primary DI is the main UDI-DI a manufacturer designates as the principal identifier for a device in EUDAMED.

07350108630139

Basic UDI-DI

Basic UDI-DI

The Basic UDI-DI is the main identifier that groups together all device variants of the same model — the regulatory "family" key.

B-07350108630139

Reference / catalog number

10-1143-01

Issuing entity

UDI issuing entities

Issuing entities are the organisations the European Commission has designated to assign Unique Device Identifiers under the EU's UDI system.

GS1

Risk category

IVDR risk classes

IVDR risk classes rank in-vitro diagnostic devices from lowest risk (Class A) to highest (Class D), based on the patient and public-health risk of a wrong result.

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 Mercodia Oxidized LDL ELISA kit is intended to be used for the in vitro quantitative measurement of oxidized low-density lipoproteins (oxidized LDL) in human serum or plasma. Lipoprotein measurements are used in the diagnosis and treatment of lipid disorders (such as diabetes mellitus), atherosclerosis, and various liver and renal diseases.

Additional information URL

https://www.mercodia.com/products/oxidized-ldl-elisa/

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.

• W0102010403APOLIPOPROTEIN B

• IVDD — General medical devices in EUDAMED

No certificate specifically references this device's Basic UDI-DI.