Eu Ivdd
Eu Ivd General
On The Market
🇨🇳 China
MYCOLOGY NA REAGENTS - OTHER
Devices (same UDI-DI)
1
Certificates
0
Countries
0
Notified Bodies
0
Basic Information
- Primary DI
- 06930317801912
- Basic UDI-DI Code
- B-06930317801912
- Reference
- DNK-2107-1
- Device Types
- None provided
- Regulation
- Eu Ivdd
- Classification
- Eu Ivd General
- Status
- On The Market
- Manufacturer
- Dynamiker Biotechnology (Tianjin) Co., Ltd.
Additional Description
The MycoMDx Candida auris PCR Assay is a multiplex polymerase chain reaction (PCR) in vitro diagnostic (IVD) test for the detection of Candida auris DNA extracted from EDTA whole blood, EDTA plasma，serum obtained from human patients considered at risk of invasive fungal disease (IFD). This kit established a method that can detect Candida auris. This method has high sensitivity and specificity, which is of great significance for the early diagnosis and treatment of invasive Candida auris infections.
CND Nomenclature Codes
| Code | Description |
|---|---|
| W0105060499 | MYCOLOGY NA REAGENTS - OTHER |
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