CanAg AFP EIA

Organization name

Fujirebio Diagnostics AB

SRN

SE-MF-000007811

Manufacturer status

Active

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• CW010

  EUDAMED did not publish a description for this code.

Primary placement in Sweden; available across 32 countries total.

Trade name

CanAg AFP EIA

UDI-DI code

17350066140371

Basic UDI-DI

B-17350066140371

Reference / catalog number

600-10

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

The CanAg AFP EIA is a manual enzyme immunometric assay intended for the quantitative determination of α‑Fetoprotein (AFP) in human serum. The assay is indicated for use as an aid in the diagnosis of hepatocellular carcinoma (HCC). The results must be interpreted in conjunction with other methods in accordance with standard clinical management guidelines.

Additional information URL

No additional information URL provided by the manufacturer.

Clinical sizes

No clinical sizes registered for this device.

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

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

• W0102039001ALPHAFETOPROTEIN

Certificate health across this manufacturer's portfolio.