Devices (same UDI-DI)
1
Certificates
0
Countries
0
Notified Bodies
0
Basic Information
- Primary DI
- 06956299702825
- Basic UDI-DI Code
- B-06956299702825
- Reference
- 801302
- Device Types
-
Single use
- Regulation
- Eu Ivdd
- Classification
- Eu Ivd General
- Status
- On The Market
- Manufacturer
- Xiamen Zeesan Biotech Co., Ltd.
Additional Description
This kit is used for in vitro qualitative detection of novel coronavirus (SARS-CoV-2) ORF1ab and N gene in samples, including nasopharyngeal swab, oropharyngeal swab, bronchoalveolar lavage fluid and stool, for diagnosis of the COVID-19 infection, the suspected cluster cases and of the patients who need differential diagnosis of COVID-19 infection.
CND Nomenclature Codes
| Code | Description |
|---|---|
| W0105900102 | REAGENTS FOR DNA AND/OR RNA AMPLIFICATION AND/OR DETECTION: BACTERIA AND/OR VIRUS |
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