Eu Ivdd
Eu Ivd General
On The Market
🇨🇳 China
SARS-CoV-2, Flu A&B Antigen, RSV, ADV, and MP Combined Detection Kit (Latex Method)
Devices (same UDI-DI)
1
Certificates
0
Countries
1
Notified Bodies
0
Basic Information
- Primary DI
- D-000012807183262QQ
- Basic UDI-DI Code
- B-000012807183262QQ
- Reference
- HWTS-RT170B
- Device Types
-
Single use
- Regulation
- Eu Ivdd
- Classification
- Eu Ivd General
- Status
- On The Market
- Manufacturer
- Jiangsu Macro & Micro-Test Med-Tech Co., Ltd.
Additional Description
This kit is used for the in vitro qualitative detection of SARS-CoV-2, influenza A&B antigens, respiratory syncytial virus, adenovirus and mycoplasma pneumoniae in nasal swab and nasopharyngeal swab samples and can be used for the differential diagnosis of SARS-CoV-2 infection, respiratory syncytial virus infection, adenovirus infection, mycoplasma pneumoniae infection and influenza A or B virus infection. The test results are for clinical reference only and cannot be used as the sole basis for diagnosis and treatment.
CND Nomenclature Codes
| Code | Description |
|---|---|
| W0105040699 | VIRAL ANTIGEN/ANTIBODY DETECTION - OTHER |
Available In Countries
🇪🇸 Spain
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