Eu Ivdd
Eu Ivd General
On The Market
🇨🇳 China
Novel Coronavirus (2019-nCoV) Nucleic Acid Detection Kit (PCR-Fluorescence Probing)
Devices (same UDI-DI)
1
Certificates
0
Countries
0
Notified Bodies
0
Basic Information
- Primary DI
- 06974677690274
- Basic UDI-DI Code
- B-06974677690274
- Reference
- ZC-HX-201-2
- Device Types
-
Single use
- Regulation
- Eu Ivdd
- Classification
- Eu Ivd General
- Status
- On The Market
- Manufacturer
- Shanghai BioGerm Medical Technology Co., Ltd.
Additional Description
This kit is an in vitro diagnosis test, for qualitative detection of Novel Coronavirus RNA (2019-nCoV, also known as SARS-CoV2) in nasopharyngeal swab, oropharyngeal swabs and sputum samples from patients with suspected 2019-nCoV infection, by targeting ORF1ab and N gene of the virus.
CND Nomenclature Codes
| Code | Description |
|---|---|
| W0105900102 | REAGENTS FOR DNA AND/OR RNA AMPLIFICATION AND/OR DETECTION: BACTERIA AND/OR VIRUS |
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