Basic Information
- Primary DI
- D-PNPLA3GenotypingCTAE7
- Basic UDI-DI Code
- B-PNPLA3GenotypingCTAE7
- Reference
- PNPLA3 Genotyping CTA
- Device Types
- None provided
- Regulation
- Eu Ivdd
- Classification
- Eu Ivd General
- Status
- On The Market
- Manufacturer
- Almac Diagnostic Services Limited
Additional Description
The PNPLA3 Genotyping Clinical Trial Assay is a qualitative polymerase chain reaction (PCR) in vitro diagnostic (IVD) assay that allows identification of the I148M (rs738409) genotype within the PNPLA3 gene from DNA isolated from whole blood samples or buccal swabs for use with the QuantStudio5™ Dx instrument. The Assay will be used to determine the PNPLA3 genotype of subjects that are candidates for clinical trials evaluating the clinical safety and effectiveness of investigational medicinal products for the treatment of non-alcoholic steatohepatitis (NASH). The CTA is intended for laboratory professional use only, and testing is to be performed only at Almac’s Clinical Laboratory Improvement Amendments (CLIA)/College of American Pathologists (CAP) accredited laboratories located at 19 Seagoe Industrial Estate, Craigavon, BT63 5QD, UK and 4238 Technology Drive, Durham, NC, USA.
CND Nomenclature Codes
| Code | Description |
|---|---|
| W010699 | GENETIC TESTS - OTHER |
Available In Countries
Similar Devices
Other on-the-market devices with the same classification (Eu Ivd General) and regulation (EU IVDD).