Accurun 1 Series 5100 positive control
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Basic Information
- Primary DI
- 00816784020765
- Basic UDI-DI Code
- B-00816784020765
- Reference
- 2000-0016
- Device Types
- None provided
- Regulation
- Eu Ivdd
- Classification
- Eu Ivd General
- Status
- On The Market
- Manufacturer
- LGC Clinical Diagnostics, Inc.
Additional Description
ACCURUN 1 controls are intended to estimate laboratory testing precision and can be used to detect errors in laboratory testing procedures. ACCURUN® 1 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 Cytomegalovirus (CMV), 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 |
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