A810 Negative Control
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Basic Information
- Primary DI
- 00816784020246
- Basic UDI-DI Code
- B-00816784020246
- Reference
- 2010-0020
- Device Types
- None provided
- Regulation
- Eu Ivdd
- Classification
- Eu Ivd General
- Status
- On The Market
- Manufacturer
- LGC Clinical Diagnostics, Inc.
Additional Description
ACCURUN® 810 Multi-Marker Negative Control has been formulated for use with in vitro diagnostic test kits for the qualitative determination of Hepatitis B Surface Antigen (HBsAg), Hepatitis B e Antigen (HBeAg), Syphilis RPR, and antibodies to Hepatitis B Surface Antigen (HBs), Hepatitis B Core Antigen (HBc and HBc IgM), Hepatitis B e Antigen (HBe), Hepatitis C Virus (HCV), Hepatitis A Virus (HAV and HAV IgM), Cytomegalovirus (CMV), Treponema pallidum (Syphilis ATA), Borrelia burgdorferi (Lyme IgG and Lyme IgM), HIV 1 and 2, and HTLV I and II
CND Nomenclature Codes
| Code | Description |
|---|---|
| W0105080899 | CONTROLS - INF. IMMUNOLOGY - OTHER |
Certificates
| Type | Number | Notified Body | Status |
|---|---|---|---|
| IVDD Annex IV (excluding sections 4, 6) | CE 572691 | BSI Group The Netherlands B.V. | Expired |
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