Eu Ivdd
Eu Ivd General
On The Market
🇭🇰 Hong Kong
CORONAVIRUS [obsolete from 2025-01-01]
Devices (same UDI-DI)
1
Certificates
0
Countries
0
Notified Bodies
0
Basic Information
- Primary DI
- 04897116730039
- Basic UDI-DI Code
- B-04897116730039
- Reference
- 2110200
- Device Types
-
Single use
- Regulation
- Eu Ivdd
- Classification
- Eu Ivd General
- Status
- On The Market
- Manufacturer
- Phase Scientific International Limited
Additional Description
The INDICAID® COVID-19 Rapid Antigen Test is a lateral flow immunoassay intended for the qualitative detection of antigens specific to SARS-CoV-2 in direct nasal and nasopharyngeal swab samples from individuals who are suspected of COVID-19 by their healthcare provider. The INDICAID® COVID-19 Rapid Antigen Test is for use by medical professionals or trained operators.
CND Nomenclature Codes
| Code | Description |
|---|---|
| W0105040619 | CORONAVIRUS [obsolete from 2025-01-01] |
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