Eu Ivdd
Eu Ivd General
On The Market
🇨🇳 China
SARS-COV-2 Realtime PCR Test Kit
Devices (same UDI-DI)
1
Certificates
0
Countries
0
Notified Bodies
0
Basic Information
- Primary DI
- 06970895476287
- Basic UDI-DI Code
- B-06970895476287
- Reference
- R205T004B0C2
- Device Types
- None provided
- Regulation
- Eu Ivdd
- Classification
- Eu Ivd General
- Status
- On The Market
- Manufacturer
- Jiangsu Mole Bioscience Co., LTD.
Additional Description
This kit uses polymerase chain reaction (PCR) technology based on TaqMan fluorescent probe to detect ORF1ab and N genes of 2019-Novel Coronavirus from specimens including oropharyngeal swabs, bronchoalveolar lavage fluid, saliva and sputum collected from the patients or suspected patients. Material includes: Buffer(nCoV3I), Primers/Probes (nCoV3T), Enzyme (nCoV3I), Positive Control (nCoV3I), Negative Control (nCoV3I)
CND Nomenclature Codes
| Code | Description |
|---|---|
| W0105040519 | CORONAVIRUS - NA REAGENTS [obsolete from 2025-01-01] |
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