Devices (same UDI-DI)
1
Certificates
0
Countries
0
Notified Bodies
0
Basic Information
- Primary DI
- 05051716000193
- Basic UDI-DI Code
- B-05051716000193
- Reference
- COV.435/300
- Device Types
- None provided
- Regulation
- Eu Ivdd
- Classification
- Eu Ivd General
- Status
- On The Market
- Manufacturer
- Oxford Immunotec Ltd
Additional Description
The T-SPOT.COVID test is a standardised ELISPOT (Enzyme Linked ImmunoSpot) based technique intended for qualitative detection of a cell mediated (T cell) immune response to SARS-CoV-2 in human whole blood (sodium or lithium heparin or sodium citrate). The T-SPOT.COVID test is intended for use as an aid in identifying and monitoring individuals with a T cell immune response to SARS-CoV-2. A T cell response to SARS-CoV-2 is generally detectable in blood several days after initial infection or vaccination, and the duration of time for detectable response post-infection or vaccination is currently not well characterised.
CND Nomenclature Codes
| Code | Description |
|---|---|
| W0105900299 | INFECTIOUS IMMUNOLOGY - OTHER |
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