Eu Ivdd
Eu Ivd General
On The Market
🇹🇷 Türkiye
RapidFor™SARS-CoV-2 + FLU A/B + RSV+ ADV Combo Rapid Test Kit
Devices (same UDI-DI)
1
Certificates
0
Countries
0
Notified Bodies
0
Basic Information
- Primary DI
- 08683548253507
- Basic UDI-DI Code
- B-08683548253507
- Reference
- VMD79
- Device Types
-
Single use
- Regulation
- Eu Ivdd
- Classification
- Eu Ivd General
- Status
- On The Market
- Manufacturer
- Vitrosens Biyoteknoloji Anonim Şirketi
Additional Description
The SARS-CoV-2 + FLU A/B + RSV + ADV Combo Test Kit is an in vitro immunochromatographic assay for the qualitative detection of SARS-CoV-2, influenza A/B, RSV and ADV antigens in nasopharyngeal 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, influenza A/ B, RSV and ADV viral infections in humans in conjunction with clinical and epidemiological risk factors.
CND Nomenclature Codes
| Code | Description |
|---|---|
| W0105090501 | CORONAVIRUS ANTIGEN (AG) - RT & POC |
| W0105099004 | INFLUENZA A AND /OR B - RT & POC |
| W0105099002 | RSV - RT & POC |
| W0105040601 | ADENOVIRUS |
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