Eu Ivdd
Eu Ivd General
On The Market
🇺🇸 United States
Accurun 2 Series 2700
Devices (same UDI-DI)
1
Certificates
1
Countries
0
Notified Bodies
1
Basic Information
- Primary DI
- 00816784020796
- Basic UDI-DI Code
- B-00816784020796
- Reference
- 2000-0024
- Device Types
- None provided
- Regulation
- Eu Ivdd
- Classification
- Eu Ivd General
- Status
- On The Market
- Manufacturer
- LGC Clinical Diagnostics, Inc.
Additional Description
ACCURUN® 2 Multi-Marker Positive Controls have been formulated for use with in vitro diagnostic test kits for the detection of antibodies to Human Immunodeficiency Virus Types 1 and 2 (HIV 1 and 2), antibodies to Human T-Lymphotropic Virus Types I and II (HTLV I and II), antibodies to Hepatitis B Core Antigen (HBcAg), antibodies to Hepatitis C Virus (HCV), antibodies to Cytomegal ovirus (CMV), antibodies to Treponema pallidum (Syphilis) and Hepatitis B Surface Antigen (HBsAg).
CND Nomenclature Codes
| Code | Description |
|---|---|
| W0105080807 | MULTICONSTITUENT CONTROLS - INF.IMM. |
Certificates
| Type | Number | Notified Body | Status |
|---|---|---|---|
| IVDD Annex IV (excluding sections 4, 6) | CE 572687 | 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