A1 Negative Control
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Basic Information
- Primary DI
- 00816784020222
- Basic UDI-DI Code
- B-00816784020222
- Reference
- 2010-0015
- Device Types
- None provided
- Regulation
- Eu Ivdd
- Classification
- Eu Ivd General
- Status
- On The Market
- Manufacturer
- LGC Clinical Diagnostics, Inc.
Additional Description
ACCURUN 1 Multi-Marker Negative Control is formulated for use with in vitro diagnostic test kits for the detection of Hepatitis B Surface Antigen (HBsAg), Human Immunodeficiency Virus Type 1 Antigen (HIV-1 Ag) and 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 Cytomegalovirus (CMV), and antibodies to Treponema pallidum (Syphilis)
CND Nomenclature Codes
| Code | Description |
|---|---|
| W0105080899 | CONTROLS - INF. IMMUNOLOGY - OTHER |
Certificates
| Type | Number | Notified Body | Status |
|---|---|---|---|
| IVDD Annex IV (excluding sections 4, 6) | CE 572687 | BSI Group The Netherlands B.V. | Expired |
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