Eu Ivdd
Eu Ivd General
On The Market
🇺🇸 United States
A21 Series 1000 CE
Devices (same UDI-DI)
1
Certificates
1
Countries
0
Notified Bodies
1
Basic Information
- Primary DI
- 00860006589707
- Basic UDI-DI Code
- B-00860006589707
- Reference
- 2000-0028
- Device Types
- None provided
- Regulation
- Eu Ivdd
- Classification
- Eu Ivd General
- Status
- On The Market
- Manufacturer
- LGC Clinical Diagnostics, Inc.
Additional Description
ACCURUN® 21 Multi-Marker Positive Controls are 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 Hepatitis B Core Antigen (HBcAg), antibodies to Hepatitis C Virus (HCV), antibodies to Hepatitis A Virus (HAV), 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 572692 | BSI Group The Netherlands B.V. | Expired |
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