SARS-CoV-2 Antigen Detection Kit (Colloidal Gold)
Basic Information
- Primary DI
- 06971042229640
- Basic UDI-DI Code
- B-06971042229640
- Reference
- CG-0003-01
- Device Types
- None provided
- Regulation
- Eu Ivdd
- Classification
- Eu Ivd General
- Status
- On The Market
- Manufacturer
- SHANGHAI ZJ BIO-TECH CO., LTD
Additional Description
The SARS-CoV-2 Antigen Detection Kit (Colloidal Gold) is a lateral flow immunoassay for the qualitative detection of nucleocapsid protein antigen from SARS-CoV-2 in direct anterior nasal swab specimens. It is intended to be used by healthcare professionals as an aid in the diagnosis of infection with SARS-CoV-2. Result is for the identification of SARS-CoV-2 nucleocapsid protein antigen. Antigen is generally detectable in anterior nasal (AN) swab specimen during the acute phase of infection. Positive result indicates the presence of viral antigens, but clinical correlation with patient history and other diagnostic information is necessary to determine infection status. Negative result should be treated as presumptive, and should not be used as the sole basis for treatment or patient management decision, including infection control decisions.
CND Nomenclature Codes
| Code | Description |
|---|---|
| W0105040619 | CORONAVIRUS [obsolete from 2025-01-01] |
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