COVID-19 SARS-CoV-2 Antigen Assay Kit (Colloidal Gold)
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Basic Information
- Primary DI
- 06970877681029
- Basic UDI-DI Code
- B-06970877681029
- Reference
- 0103
- Device Types
-
Single use
- Regulation
- Eu Ivdd
- Classification
- Eu Ivd General
- Status
- On The Market
- Manufacturer
- Kangmei Tianhong Biotech (Beijing) Co., Ltd.
Additional Description
COVID-19 Antigen Assay Kit (Colloidal Gold Method) is a lateral flow immunoassay for the qualitative detection of nucleaocapsid protein from SARS-CoV-2 in nasopharyngeal swab. It is intended to be used by professionals as a test and provides a preliminary test result to aid in the diagnosis of infection with novel Coronavirus. Any interpretation or use of this preliminary test result must also rely on other clinical findings as well as on the professional judgment of health care providers. Alternative test method(s) should be considered to confirm the test result obtained by this test.
CND Nomenclature Codes
| Code | Description |
|---|---|
| W01021699 | RAPID TESTS & POINT OF CARE - IMMUNOCHEMISTRY - OTHER |
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