CYSTIC FIBROSIS
Let the assistant research this device
The Research Assistant compiles risk class, certificates, notified bodies and related records โ and cites every one.
Free to try ยท every answer cites its records
Basic Information
- Primary DI
- D-9018BH
- Basic UDI-DI Code
- B-9018BH
- Reference
- RC-CFTR096-I
- Device Types
- None provided
- Regulation
- Eu Ivdd
- Classification
- Eu Ivd General
- Status
- No Longer On The Market
- Manufacturer
- NimaGen BV
Additional Description
The intended purpose of this assay is NGS library preparation for Illuminaยฎ sequencing of the human CFTR gene coding exons, including a minimum of 20 bases upstream and downstream of each exon; to aid in the diagnosis of (the congenital predisposition to) cystic fibrosis by detecting sequence variants. This assay also includes 2 intronic hotspot mutations. The assay is designed for use with DNA extracted from peripheral blood. Specimens should have an absorbance ratio (260/280) of ~1.8, regardless of the extraction method used. The assay provides reagents for Multiplex Amplicon based NGS library preparation and is for professional use only. The kit is based on the patented Reverse Complement PCR technology, providing a safe, robust and simple workflow, combining multiplex amplification in a single reaction, decreasing risk for PCR contamination and sample swapping.
CND Nomenclature Codes
| Code | Description |
|---|---|
| W0106010101 | CYSTIC FIBROSIS |
Available In Countries
Similar Devices
Other on-the-market devices with the same classification (Eu Ivd General) and regulation (EU IVDD).