Eu Ivdd Eu Ivd General On The Market 🇺🇸 United States

A1 Negative Control

LGC Clinical Diagnostics, Inc. · 🇺🇸 United States
Devices (same UDI-DI)
1
Certificates
1
Countries
0
Notified Bodies
1

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

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
IVDD Annex IV (excluding sections 4, 6) CE 572687

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