Bacterial Endotoxin Test (Chromogenic Method)

Trade name

Bacterial Endotoxin Test (Chromogenic Method)

UDI-DI code

06970489560323

Basic UDI-DI

B-06970489560323

Reference / catalog number

EKT-5M

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

Be used to provide rapid diagnosis reference for clinical Gram-negative bacterial infection through qualitative detection of Gram-negative bacterial lipopolysaccharide (that is bacterial endotoxin) in the serum. The kit should be used in conjunction with other diagnostic procedures, such as microbiological culture, histological examination of biopsy samples and radiological examination.

Additional information URL

No additional information URL provided by the manufacturer.

Clinical sizes

No clinical sizes registered for this device.

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

• W0105011799BACTERIOLOGY IMMUNOASSAY - OTHER

1 warning recorded — scroll inside the panel to see all entries.

• CW010

  EUDAMED did not publish a description for this code.

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