Eu Ivdd
Eu Ivd General
On The Market
🇨🇳 China
Saliva SARS-CoV-2(2019-nCoV) Antigen Test Kit ( Latex microspheres Assay )
Devices (same UDI-DI)
1
Certificates
0
Countries
0
Notified Bodies
0
Basic Information
- Primary DI
- 16975783510033
- Basic UDI-DI Code
- B-16975783510033
- Reference
- NBMLRS-XG-S6
- Device Types
-
Single use
- Regulation
- Eu Ivdd
- Classification
- Eu Ivd General
- Status
- On The Market
Additional Description
Saliva SARS-CoV-2 (2019-nCoV) Antigen Test Kit (Latex microspheres Assay) is a lateral flow, one-step immunoassay for the qualitative detection of N antigen in Saliva sample. This product is used to obtain a visual, qualitative results and is intended for professional use. This assay provides only a preliminary analytical test result. A more specific alternate method must be used in order to obtain a confirmed analytical result. The RT-PCR Test is the preferred confirmatory method.
CND Nomenclature Codes
| Code | Description |
|---|---|
| W01021699 | RAPID TESTS & POINT OF CARE - IMMUNOCHEMISTRY - OTHER |
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