Eu Ivdd
Eu Ivd General
On The Market
🇹🇼 Taiwan
VitaPCR SARS-CoV-2 External Control Set
Devices (same UDI-DI)
1
Certificates
0
Countries
0
Notified Bodies
0
Basic Information
- Primary DI
- 04719878570176
- Basic UDI-DI Code
- B-04719878570176
- Reference
- PCRAE0115
- Device Types
-
Single use
- Regulation
- Eu Ivdd
- Classification
- Eu Ivd General
- Status
- On The Market
- Manufacturer
- Credo Diagnostics Biomedical Pte. Ltd. Taiwan Branch
Additional Description
The VitaPCR™ SARS-CoV-2 External Control Set performed on the VitaPCR™ Instrument is intended to be used for quality control testing. This External positive control for use with VitaPCR™ SARS-CoV-2 assay contains noninfectious in vitro transcribed RNA in a dried state and must be resuspended before use. The negative control consists of a synthetic human Beta-globin (HBB) DNA segment in a dried state and must be resuspended before use.
CND Nomenclature Codes
| Code | Description |
|---|---|
| W0105080808 | ALL INFECTIOUS DISEASES CONTROLS - NAT |
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