Eu Ivdd
Eu Ivd General
On The Market
🇨🇳 China
TESTS FOR ACQUIRED GENETIC OR CHROMOSOMAL ALTERATIONS - OTHER
Devices (same UDI-DI)
1
Certificates
0
Countries
0
Notified Bodies
0
Basic Information
- Primary DI
- 06959094209490
- Basic UDI-DI Code
- B-06959094209490
- Reference
- 8.01.0228
- Device Types
- None provided
- Regulation
- Eu Ivdd
- Classification
- Eu Ivd General
- Status
- On The Market
- Manufacturer
- Amoy Diagnostics Co., LTD.
Additional Description
The AmoyDx ® Novel Coronavirus (2019-nCoV) Detection Kit is a real-time reverse transcription (RT)-PCR assay for qualitative detection of novel coronavirus SARS-CoV-2. The kit is intended use with viral RNA extracted from human upper and lower respiratory specimens. The kit is intended to be used by trained professionals in a laboratory environment.
CND Nomenclature Codes
| Code | Description |
|---|---|
| W01060299 | TESTS FOR ACQUIRED GENETIC OR CHROMOSOMAL ALTERATIONS - OTHER |
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