GENETIC TESTS - OTHER
Basic Information
- Primary DI
- D-APOL1GenotypingCTABF
- Basic UDI-DI Code
- B-APOL1GenotypingCTABF
- Reference
- APOL1 Genotyping CTA
- Device Types
- None provided
- Regulation
- Eu Ivdd
- Classification
- Eu Ivd General
- Status
- No Longer On The Market
- Manufacturer
- Almac Diagnostic Services Limited Liability Company
Additional Description
The APOL1 Genotyping Clinical Trial Assay (CTA) is a qualitative polymerase chain reaction (PCR) in vitro diagnostic (IVD) assay that allows allelic discrimination of rs73885319 G1(S342G) and rs71785313 G2(ฮ6) genotypes within the APOL1 gene from deoxyribonucleic acid (DNA) derived from whole blood and buccal swabs collected in PAXgene DNA Blood Collection Tubes and Mawi DNA iSWAB-Discovery Buccal Tubes, respectively, for use with the QuantStudioโข Dx instrument. The Assay will be used to determine the APOL1 genotype of subjects that are candidates for clinical trials evaluating the clinical safety and effectiveness of investigational medicinal products for the treatment of kidney disease. The Assay is intended for laboratory professional use only, to be performed only at Almac Diagnostic Servicesโ Clinical Laboratory Improvement Amendments (CLIA)/College of American Pathologists (CAP) accredited laboratory located at 4238 Technology Drive, Durham, North Carolina, 27704, 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).