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Our data is continuously updated and sourced from EUDAMED, the European database for medical devices and in vitro diagnostics.

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Organization name
UDI-DI code
Reference / catalog number

K 8213 — IVDD — General IVDD by Immundiagnostik AG

MD Atlas
Immundiagnostik AG

EUDAMED last updated this device on May 20, 2026

K 8213

B-04050598001121

On the marketIVDD — General

Applicable legislation: IVDD [Directive 98/79/EC on in vitro diagnostic medical devices]
Organization name: Immundiagnostik AG
UDI-DI code: 04050598001121
Reference / catalog number: K 8213

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Manufacturer information

Organization name: Immundiagnostik AG
SRN: DE-MF-000020905
Manufacturer status: Active

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Certificates

No certificates registered for this manufacturer.

No certificate references this Basic UDI-DI, because: • It does not require a certificate, or • It only requires a certificate without a Basic UDI-DI reference (e.g. a QMS certificate), or • The required certificate(s) referencing this Basic UDI-DI have not been registered yet.

Critical warnings

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

CW018
EUDAMED did not publish a description for this code.

Market distribution

Primary placement in Germany; available across 1 country total.

Country	On market since	Until
GermanyPrimary placement		Still on market

Device identification

Trade name: not provided
UDI-DI code: 04050598001121
Basic UDI-DI: B-04050598001121
Reference / catalog number: K 8213
Issuing entity: GS1

Classification

Risk category: IVDD — General
Applicable legislation: IVDD [Directive 98/79/EC on in vitro diagnostic medical devices]
Status: On the market

Device details

Quantity: 1
Additional product description: The histamine assay K 8213 is an enzyme-linked immunosorbent assay (ELISA) intended for professional laboratory users for the quantitative detection of the free histamine concentration in stool from patients of any age and gender. The assay is an in vitro diagnostic medical device, which can be used manually or by an automated platform. The detection of an elevated gastrointestinal histamine concentration in the stool of a patient is used as a diagnostic aid to inform the treating therapist about the necessity to prescribe appropriate dietetic interventions, such as the intake of probiotics or the recommendation of a low-histamine´diet
Additional information URL: No additional information URL provided by the manufacturer.
Clinical sizes: No clinical sizes registered for this device.

EMDN nomenclature code(s)

W01020209HISTAMINE

Compliance flags

Safety

Sterile

Single use

Direct marking

Regulatory

Sterilization

Lifecycle

New device

UDI-PI traceability

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