GENETIC TESTS - OTHER
Basic Information
- Primary DI
- D-BIPSNPCTATJ
- Basic UDI-DI Code
- B-BIPSNPCTATJ
- Reference
- BIP SNP 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 BIP SNP CTA is an investigational qualitative qPCR in vitro diagnostic (IVD) assay that allows allelic discrimination of (rs1718119) (Ala348Thr), (rs3751143) (Glu496Ala) and (rs1653624) (Ile568Asn), in the P2X7 gene from DNA derived from whole blood samples collected in PAXgene DNA Blood Collection Tubes from patients with bipolar disorder. The assay is intended for use with the QuantStudio 5 Dx instrument. The assay will be used for the purposes of screening of whole blood samples collected as part of clinical trial evaluating the safety and effectiveness of the investigational therapeutic JNJ-55308942. The BIP SNP CTA is intended for investigational use only, with testing to be performed at Almac Diagnostic Servicesโ Clinical Laboratory Improvement Amendments (CLIA)/College of American Pathologists (CAP) accredited laboratory located at 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).