CanAg CA125 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 CA125 EIA

UDI-DI code

17350066140241

Basic UDI-DI

B-17350066140241

Reference / catalog number

400-10

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 CA 125 EIA is a manual enzyme immunometric assay intended for the quantitative determination of the cancer associated antigen CA 125 in human serum. The assay is indicated for use in the measurement of CA 125 antigen to aid in the management of ovarian cancer patients. Serial testing for CA 125 antigen concentrations should be used in conjunction with other clinical methods for monitoring ovarian cancer. The assay is further intended to be used in conjunction with HE4 EIA as an aid in estimating the risk of epithelial ovarian cancer in premenopausal and postmenopausal women presenting with pelvic mass. 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.

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• Expiration date
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• Software identification

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

• W0102030106CANCER ANTIGEN 125

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