Myeloperoxidase (MPO) Assay Test Kit (Immunoturbidimetric Method)

Organization name

Biobase Biodustry(Shandong) Co.,Ltd.

SRN

CN-MF-000025015

Manufacturer status

Active

Primary placement in Germany; available across 1 country total.

Trade name

Myeloperoxidase (MPO) Assay Test Kit (Immunoturbidimetric Method)

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.

06936895300519

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-06936895300519

Reference / catalog number

R1:48mL×2 R2:16mL×2(713)

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

This reagent is intended for the in vitro quantitative determination of myeloperoxidase in human serum. Myeloperoxidase (MPO) is a hemoglobin protein in white blood cells. MPO is an enzyme that regulates the redox reaction of iron halides, which produces a strong oxidant similar to hypochlorous acid, which is an effective antibacterial agent against a large number of parasites and pathogenic bacteria. Therefore, MPO plays an important role in the self-defense tact of humans and animals. However, while initiating oxidative reactions, MPO also damages its own tissues through lipid and protein peroxidation, resulting in cardiovascular inflammation. It is well known that plasma MPO levels are sensitive indicators of cardiovascular and other chronic inflammation. In addition, studies have shown that blood MPO levels are associated with the risk of stroke, angina, and myocardial infarction. In clinic, the detection method of myeloperoxidase are latex immunoturbidimetry, fluorescence immunochromatography and so on.For professional use only.

Additional information URL

No additional information URL provided by the manufacturer.

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

• IVDD — General medical devices in EUDAMED

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