Basic Information
- Primary DI
- D-HSD17B13GenotypingCTA7C
- Basic UDI-DI Code
- B-HSD17B13GenotypingCTA7C
- Reference
- HSD17B13 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 HSD17B13 Genotyping Clinical Trial Assay (CTA) is a qualitative polymerase chain reaction (PCR) in vitro diagnostic (IVD) assay that allows allelic discrimination of rs72613567 (Adenine insertion) within the HSD17B13 gene from DNA derived from whole blood or buccal swabs for use with the QuantStudio5™ Dx instrument. The assay will be used to determine the HSD17B13 genotype; the homozygous non-risk adenine insertion (TA/TA), the heterozygous risk variant (T/TA) or the homozygous risk variant (T/T) 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 HSD17B13 Genotyping CTA is intended for laboratory professional use only, with testing to be performed at Almac Diagnostic Services’ 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, US.
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).