Eu Ivdd
Eu Ivd General
On The Market
🇺🇸 United States
ACCURUN 345 HIV-1 RNA, HCV RNA, HBV DNA Positive Quality Control Series 150
Devices (same UDI-DI)
1
Certificates
1
Countries
0
Notified Bodies
1
Basic Information
- Primary DI
- 00816784020611
- Basic UDI-DI Code
- B-00816784020611
- Reference
- 2020-0104
- Device Types
- None provided
- Regulation
- Eu Ivdd
- Classification
- Eu Ivd General
- Status
- On The Market
- Manufacturer
- LGC Clinical Diagnostics, Inc.
Additional Description
ACCURUN® 345 HIV-1 RNA, HCV RNA, HBV DNA Positive Quality Control Series 150 is formulated for use with in vitro diagnostic test methods that detect HIV-1 RNA, HCV RNA and HBV DNA.
CND Nomenclature Codes
| Code | Description |
|---|---|
| W0105080807 | MULTICONSTITUENT CONTROLS - INF.IMM. |
Certificates
| Type | Number | Notified Body | Status |
|---|---|---|---|
| IVDD Annex IV (excluding sections 4, 6) | CE 572685 | BSI Group The Netherlands B.V. | Expired |
Similar Devices
Other on-the-market devices with the same classification (Eu Ivd General) and regulation (EU IVDD).
BluBox
Device
EU IVDD
·
Eu Ivd General
·Blusense Diagnostics ApS·On the market·5 countries
extendSURE™ HbA1c Liquid Controls
Device
EU IVDD
·
Eu Ivd General
·Canterbury Scientific Limited·On the market·19 countries
ViroTrack Sero COVID-19 Total Ab
Device
EU IVDD
·
Eu Ivd General
·Blusense Diagnostics ApS·On the market·5 countries
extendSURETM Haemoglobin F and A2 Calibrators
Device
EU IVDD
·
Eu Ivd General
·Canterbury Scientific Limited·On the market·8 countries
extendSURE™ Haemoglobin F and A2 Controls
Device
EU IVDD
·
Eu Ivd General
·Canterbury Scientific Limited·On the market·8 countries
extendSURE™ HbA1c Liquid Controls
Device
EU IVDD
·
Eu Ivd General
·Canterbury Scientific Limited·On the market·19 countries