Eu Ivdd
Eu Ivd General
On The Market
🇨🇳 China
First Sign®
Devices (same UDI-DI)
1
Certificates
0
Countries
0
Notified Bodies
0
Basic Information
- Primary DI
- D-WHATOCOVAg01U4
- Basic UDI-DI Code
- B-WHATOCOVAg01U4
- Reference
- WH-AT-OCOV010202
- Device Types
-
Single use
- Regulation
- Eu Ivdd
- Classification
- Eu Ivd General
- Status
- On The Market
- Manufacturer
- W.H.P.M. Bioresearch & Technology Co., Ltd.
Additional Description
The First Sign® SARS-CoV-2 Antigen Test is a rapid lateral flow chromatographic immunoassay for the qualitative detection of SARS-CoV-2 antigens in nasopharyngeal swab (NP), anterior nasal swab (NS) and oropharyngeal swab (OS) specimens from individuals suspected of COVID-19 by their healthcare provider within the first seven days of symptom onset. An antigen is generally detectable in upper respiratory specimens during the acute phase of infection.
CND Nomenclature Codes
| Code | Description |
|---|---|
| W0105040619 | CORONAVIRUS [obsolete from 2025-01-01] |
Similar Devices
Other on-the-market devices with the same classification (Eu Ivd General) and regulation (EU IVDD).
BluBox
Device
EU IVDD
·
Eu Ivd General
·Blusense Diagnostics ApS·On the market·5 countries
extendSURE™ HbA1c Liquid Controls
Device
EU IVDD
·
Eu Ivd General
·Canterbury Scientific Limited·On the market·19 countries
ViroTrack Sero COVID-19 Total Ab
Device
EU IVDD
·
Eu Ivd General
·Blusense Diagnostics ApS·On the market·5 countries
extendSURETM Haemoglobin F and A2 Calibrators
Device
EU IVDD
·
Eu Ivd General
·Canterbury Scientific Limited·On the market·8 countries
extendSURE™ Haemoglobin F and A2 Controls
Device
EU IVDD
·
Eu Ivd General
·Canterbury Scientific Limited·On the market·8 countries
extendSURE™ HbA1c Liquid Controls
Device
EU IVDD
·
Eu Ivd General
·Canterbury Scientific Limited·On the market·19 countries