Zika IgG/IgM Rapid Test Cassette(Whole Blood/Serum/Plasma)

Trade name

Zika IgG/IgM Rapid Test Cassette(Whole Blood/Serum/Plasma)

UDI-DI code

D-GCZIK(IgG/IgM)-T402a3U

Basic UDI-DI

B-GCZIK(IgG/IgM)-T402a3U

Reference / catalog number

GCZIK(IgG/IgM)-T402a

Issuing entity

EUDAMED

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 Zika IgG/IgM Rapid Test Cassette (Whole Blood/Serum/Plasma) is a rapid lateral flow chromatographic immunoassay intended for the qualitative and rapid detection of immunoglobulin G (IgG) and immunoglobulin M (IgM) against Zika virus in human whole blood, serum or plasma. This test serves as an aid in the clinical laboratory diagnosis of patients with clinical symptoms consistent with zika disease. Results are preliminary, and any reactive specimen with the Zika IgG/IgM Rapid Test Cassette (Whole Blood/Serum/Plasma) must be confirmed with alternative testing method(s) and clinical findings. For professional use only. For in vitro diagnostic use only.

Additional information URL

No additional information URL provided by the manufacturer.

Clinical sizes

No clinical sizes registered for this device.

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

• W0105040630ZIKA VIRUS

3 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.
• CW007

  EUDAMED did not publish a description for this code.

No certificate specifically references this device's Basic UDI-DI.