Devices (same UDI-DI)
1
Certificates
0
Countries
0
Notified Bodies
0
Basic Information
- Primary DI
- 08719327031834
- Basic UDI-DI Code
- B-08719327031834
- Reference
- 2331633
- Device Types
-
Single use
- Regulation
- Eu Ivdd
- Classification
- Eu Ivd General
- Status
- On The Market
- Manufacturer
- Microbe&Lab B.V.
Additional Description
The CeliaSCAN HLA-DQ2.5, HLA-DQ2.2 and HLA-DQ8 Assay kit is intended to be used for in vitro detection of the MHC class II HLA-DQ2.5 (hetero- and homozygous), HLA-DQ8, HLA-DQ2.2 and HLA-DQA1*05 markers in human DNA. The intended user will be a specialized molecular diagnostic laboratory. The test will be carried out by trained laboratory personnel. No special training will be required for professional routine diagnostic laboratories performing quantitative polymerase chain reaction (PCR).
CND Nomenclature Codes
| Code | Description |
|---|---|
| W010699 | GENETIC TESTS - OTHER |
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