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
- 06930317801950
- Basic UDI-DI Code
- B-06930317801950
- Reference
- DNK-2110-1
- Device Types
- None provided
- Regulation
- Eu Ivdd
- Classification
- Eu Ivd General
- Status
- On The Market
- Manufacturer
- Dynamiker Biotechnology (Tianjin) Co., Ltd.
Additional Description
The Talaromyces marneffei PCR Assay is a multiplex polymerase chain reaction (PCR) in vitro diagnostic (IVD) test for the detection of Talaromyces marneffei DNA extracted from EDTA whole blood, EDTA plasma,serum and bronchoalveolar lavage fluid (BALF)obtained from human patients considered at risk of invasive fungal disease (IFD). This kit established a method that can simultaneously detect Talaromyces marneffei. This method has high sensitivity and specificity, which is of great significance for the early diagnosis and treatment of invasive Talaromyces marneffei infections.
CND Nomenclature Codes
| Code | Description |
|---|---|
| W0105060499 | MYCOLOGY NA REAGENTS - OTHER |
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