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ImmunoCAP Antigen Gm24, Stachybotrys atra

EUDAMED

Class B (EU MDR)

Ref 14-5304-01

by Phadia AB

Identity

Trade Name
ImmunoCAP Antigen Gm24, Stachybotrys atra EUDAMED
Device Name
ImmunoCAP Specific IgG EUDAMED
Model / Reference
14-5304-01 EUDAMED

Identifiers

Primary DI / UDI-DI
07333066009896 EUDAMED
Basic UDI-DI
7333066BUDI0058MD EUDAMED
EMDN Code
W0102010105 IMMUNOGLOBULIN G EUDAMED

Classification

Device Class
Class B EUDAMED
Market of Registration
Sweden EUDAMED

Clinical & Handling

Sterile

No

EUDAMED

Human Tissues

No

EUDAMED

Animal Tissues

No

EUDAMED

Microbial Substances

Yes

EUDAMED

Reagent

Yes

EUDAMED

Self Testing

No

EUDAMED

Near-Patient Testing

No

EUDAMED

Professional Testing

Yes

EUDAMED

Companion Diagnostics

No

EUDAMED

Surgical Instrument

No

EUDAMED

New Device

No

EUDAMED

Category: Human immunoglobulin G (IgG) animal conjugate antibody reagent IVD

ImmunoCAP Antigen Gm24, Stachybotrys atra by Phadia AB — Class B — IVDR — listed in EUDAMED — regulatory data on deviCERTS

Similar devices

Also classified as Human immunoglobulin G (IgG) animal conjugate antibody reagent IVD.

Authorization Coverage (European Union — 27 member states)

Regulatory Authorizations

European Union Active

CE/IVDR

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Manufacturer

Manufacturer
Phadia AB
EUDAMED SRN
SE-MF-000014170

Sources (1)

  • EUDAMED 55d207c5-68ac-45fa-aeea-e6c486212ff9 61 fields · synced Jul 29, 2026