RE59221

Organization name

IBL International GmbH

SRN

DE-MF-000015709

Manufacturer status

Active

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

• CW010

  EUDAMED did not publish a description for this code.
• CW267

  EUDAMED did not publish a description for this code.

Primary placement in Germany; available across 32 countries total.

Trade name

not provided

UDI-DI code

04049325033177

Basic UDI-DI

4049325IVR06030000BRB

Reference / catalog number

RE59221

Issuing entity

GS1

Risk category

IVDR Class B

Applicable legislation

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

Status

On the market

Quantity

1

Additional product description

Enzyme immunoassay for the quantitative determination of histamine in human EDTA plasma and urine. The Histamine ELISA is useful as an aid for diagnosis of allergic disorders by assessing the patient's health status using the physiological marker histamine. Of clinical interest in the histamine determination is the quantification of the histamine release from basophilic leukocytes in allergies of the "immediate type" as well as of the histamine quantity which is present in various body fluids (plasma, urine), after allergen administration. Patient population includes adults suspected to be affected by allergies. The Histamine ELISA is a solid phase enzyme-linked immunosorbent assay (ELISA), based on the principle of competitive binding and measured on an absorbance reader. The assay is semi-automated requiring general purpose laboratory instruments and consumables such as absorbance microplate reader/washer, vortexer and pipettes to execute the test. Test results may be calculated from a standard curve and compared to laboratory established reference ranges from healthy adults (i.e. normal ranges). The test kit is intended for professional laboratory use only. The test kit is not for self-testing. The Histamine ELISA is NOT intended for near-patient testing.

Additional information URL

No additional information URL provided by the manufacturer.

Clinical sizes

No clinical sizes registered for this device.

• W01020209HISTAMINE

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