Sentosa SQ HCV Genotyping Assay Bundle (4x16)
Basic Information
- Primary DI
- 08885013956603
- Basic UDI-DI Code
- B-08885013956603
- Reference
- 690018
- Device Types
-
Single use
- Regulation
- Eu Ivdd
- Classification
- Eu Ivd Annex 2 List A
- Status
- On The Market
- Manufacturer
- Vela Operations Singapore Pte. Ltd.
Additional Description
The Sentosa® SQ HCV Genotyping Assay (4x16) is a next generation sequencing-based in vitro diagnostic test intended for viral genotyping in patients diagnosed with Hepatitis C Virus infection from human plasma or serum. This test is intended to be used on the Sentosa® SX101 with the Sentosa® SX Virus Total Nucleic Acid Plus II Kit (4x16) in conjunction with the Sentosa® ST401 and Sentosa® SQ301 instruments. The genotyping information from this test will help in the management of patients with HCV. Results should be used in conjunction with other available laboratory and clinical information and are not intended for use as a stand-alone diagnostic test.
CND Nomenclature Codes
| Code | Description |
|---|---|
| W0105020309 | HEPATITIS C VIRUS (HCV) GENOTYPING - NA REAGENTS |
Certificates
| Type | Number | Notified Body | Status |
|---|---|---|---|
| IVDD Annex IV (excluding sections 4, 6) | HL 2074998-1 | TÜV Rheinland LGA Products GmbH | Expired |
| IVDD Annex IV Section 4 | IL 2074998-1 | TÜV Rheinland LGA Products GmbH | Expired |
Similar Devices
Other on-the-market devices with the same classification (Eu Ivd Annex 2 List A) and regulation (EU IVDD).