Eu Ivdr
Eu Ivd Class A
On The Market
🇸🇬 Singapore
ViroKey SX Virus Total Nucleic Acid (4x48)
Devices (same UDI-DI)
2
Certificates
0
Countries
0
Notified Bodies
0
Basic Information
- Primary DI
- 08885013958218
- Basic UDI-DI Code
- 888501395VKVTNA2S
- Reference
- 300678
- Device Types
-
Single use
- Regulation
- Eu Ivdr
- Classification
- Eu Ivd Class A
- Status
- On The Market
- Manufacturer
- Vela Operations Singapore Pte. Ltd.
Additional Description
The ViroKey SX Virus Total Nucleic Acid Kit (4x48) is used for magnetic beads-based nucleic acid extraction from SARS-CoV-2 in nasopharyngeal, oropharyngeal swab samples and saliva in conjunction with the ViroKey SARS-CoV-2 RT-PCR Test v2.0 (8x48) on the Sentosa® SX101 instrument or Sentosa SX101 and Thermo Fisher KingFisher Flex instrument combination.
CND Nomenclature Codes
| Code | Description |
|---|---|
| W0105900101 | REAGENTS FOR DNA AND/OR RNA EXTRACTION AND PREPARATION: BACTERIA AND/OR VIRUS |
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