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Eu Ivd Self Testing
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RapidFor™ SARS-CoV-2 Rapid Antigen Test (Nasal)
Devices (same UDI-DI)
1
Certificates
1
Countries
0
Notified Bodies
1
Basic Information
- Primary DI
- 08683548250001
- Basic UDI-DI Code
- B-08683548250001
- Reference
- VSCD02ST01
- Device Types
-
Single use
- Regulation
- Eu Ivdd
- Classification
- Eu Ivd Self Testing
- Status
- On The Market
- Manufacturer
- Vitrosens Biyoteknoloji Anonim Şirketi
Additional Description
The RapidFor™ SARS-CoV-2 Rapid Antigen Test (Nasal) is a lateral flow test for the qualitative detection of SARS-CoV-2 nucleocapsid antigen in human nasal swab specimens. The kit provides a rapid, on-the-spot result on the possible presence of COVID-19 infection in the individual person being tested. The test kit is designed for self-testing and does not require any special training for sample collection, processing, or test operation.
CND Nomenclature Codes
| Code | Description |
|---|---|
| W0105040619 | CORONAVIRUS [obsolete from 2025-01-01] |
| W0105099099 | VIROLOGY - RT & POC - OTHER |
Certificates
| Type | Number | Notified Body | Status |
|---|---|---|---|
| IVDD Annex III Section 6 | 1435-IVDD-252/2022 | POLSKIE CENTRUM BADAN I CERTYFIKACJI S.A. | Expired |
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