Eu Ivdd
Eu Ivd General
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🇹🇷 Türkiye
RapidFor™ SARS-CoV-2 & FLU A/B Rapid Antigen Test Kit
Devices (same UDI-DI)
1
Certificates
0
Countries
0
Notified Bodies
0
Basic Information
- Primary DI
- 08683548252159
- Basic UDI-DI Code
- B-08683548252159
- Reference
- VSCD08
- Device Types
-
Single use
- Regulation
- Eu Ivdd
- Classification
- Eu Ivd General
- Status
- On The Market
- Manufacturer
- Vitrosens Biyoteknoloji Anonim Şirketi
Additional Description
The RapidFor™ SARS-CoV-2 & FLU A/B Rapid Antigen Test Kit is an in vitro immunochromatographic assay for the qualitative detection of SARS-CoV-2 and influenza A / B antigens in nasopharyngeal and nasal swab specimens collected from patients with signs and symptoms of respiratory infection. This test is intended for use as an aid in the differential diagnosis of SARS-CoV-2 and influenza A/ B viral infections in humans in conjunction with clinical and epidemiological risk factors.
CND Nomenclature Codes
| Code | Description |
|---|---|
| W0105040604 | INFLUENZA & PARA INFLUENZA |
| W0105099099 | VIROLOGY - RT & POC - OTHER |
| W0105040619 | CORONAVIRUS [obsolete from 2025-01-01] |
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