Eu Ivdd
Eu Ivd General
On The Market
🇨🇳 China
REAGENTS FOR DNA AND/OR RNA AMPLIFICATION AND/OR DETECTION: BACTERIA AND/OR VIRUS
Devices (same UDI-DI)
1
Certificates
0
Countries
0
Notified Bodies
0
Basic Information
- Primary DI
- 06973492240572
- Basic UDI-DI Code
- B-06973492240572
- Reference
- U202024-20
- Device Types
-
Single use
- Regulation
- Eu Ivdd
- Classification
- Eu Ivd General
- Status
- On The Market
- Manufacturer
- Ustar Biotechnologies (Hangzhou) Ltd.
Additional Description
This assay is intended for qualitative detection of SARS-CoV-2 and SARS-CoV-2 Delta variant. It detects SARS-CoV-2 and characteristic mutations of SARS-CoV-2 Delta variant using oropharyngeal swab, nasopharyngeal swab samples from patients who have been diagnosed of COVID-19.
CND Nomenclature Codes
| Code | Description |
|---|---|
| W0105900102 | REAGENTS FOR DNA AND/OR RNA AMPLIFICATION AND/OR DETECTION: BACTERIA AND/OR VIRUS |
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