2019-nCoV IgG/IgM Detection Kit (Colloidal Gold-Based）

Trade name

2019-nCoV IgG/IgM Detection Kit (Colloidal Gold-Based）

UDI-DI code

06973315730747

Basic UDI-DI

B-06973315730747

Reference / catalog number

C6603C

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

This test kit is suitable for in vitro qualitative detection of 2019-novel coronavirus (2019-nCoV) IgM/IgG antibodies in human serum or plasma. This test kit is only used as a supplementary detection marker for suspected cases with negative 2019-nCoV nucleic acid test result, or for diagnosis of suspected cases in conjunction with nucleic acid test. The test result of this kit should not be used as a basis for diagnosis and elimination of COVID-19. This test kit is not suitable for screening of general population. The product can only be used by medical institutions. Positive test results need further confirmation. Negative test results cannot rule out the possibility of 2019-nCoV infection. The test kit is limited to clinical use and emergency stockpiles. It cannot be used in clinic as routine in vitro diagnostic reagent. The test result of this kit is for clinical reference only. It is suggested that the patients' clinical manifestations and other laboratory tests should be combined to make a comprehensive analysis of patients

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.

• W0105090502CORONAVIRUS ANTIBODY (AB) - RT & POC

1 warning recorded — scroll inside the panel to see all entries.

• CW007

  EUDAMED did not publish a description for this code.

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