abia HEV IgG

Organization name

AB Diagnostic Systems GmbH

SRN

DE-MF-000025407

Manufacturer status

Active

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

• CW010

  EUDAMED did not publish a description for this code.
• CW009

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

  EUDAMED did not publish a description for this code.
• CW266

  EUDAMED did not publish a description for this code.
• CW007

  EUDAMED did not publish a description for this code.
• CW082

  EUDAMED did not publish a description for this code.
• CW085

  EUDAMED did not publish a description for this code.
• CW422

  EUDAMED did not publish a description for this code.
• CW162

  EUDAMED did not publish a description for this code.
• CW167

  EUDAMED did not publish a description for this code.
• CW416

  EUDAMED did not publish a description for this code.
• CW397

  EUDAMED did not publish a description for this code.

Primary placement in Germany; available across 5 countries total.

Trade name

abia HEV IgG

UDI-DI code

04262351590296

Basic UDI-DI

B-04262351590296

Reference / catalog number

DK.029.01.3

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

In-vitro-diagnostic test kit intended for the qualitative detection of IgG antibodies to hepatitis E virus (HEV) in human serum or plasma.

Additional information URL

No additional information URL provided by the manufacturer.

Clinical sizes

No clinical sizes registered for this device.

• W0105020504HEV ANTIBODY IGG

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