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Controls/standards/calibrators - (infect. immunology/nat)
Controls/standards/calibrators - (infect. immunology/nat)
W010508
771 devices
Subcategories
2
W01050808
Controls - infect. immunology
743
devices
›
W01050809
Standards and calibrators - infect. immunology/nat
28
devices
›
Devices
ACCURUN 51 Multi-Marker Hepatitis Positive Control 1 Series 3000
LGC Clinical Diagnostics, Inc.
·
,
United States
IVD General
CE/IVDD
HAV IgM and HEV IgM Multi Control
Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
·
,
China
Class C
CE/IVDR
HEV IgG Control
Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
·
,
China
Class C
CE/IVDR
A325 Series 200 HBV DNA
LGC Clinical Diagnostics, Inc.
·
,
United States
IVD General
CE/IVDD
GUDID
on market
Access anti-HAV QC
Beckman Coulter, Inc.
·
,
United States
Class B
FDA 510(k)
K243846
Active
Cleared 9 Sep 2025
CE/IVDR
Anti-HAV Control
Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
·
,
China
Class C
CE/IVDR
ACCURUN 305 Series 150 HCV RNA Positive Control
LGC Clinical Diagnostics, Inc.
·
,
United States
IVD General
CE/IVDD
GUDID
on market
A51 Hepatitis Multi-Marker
LGC Clinical Diagnostics, Inc.
·
,
United States
IVD General
CE/IVDD
GUDID
on market
A115 Anti-HBc IgG
LGC Clinical Diagnostics, Inc.
·
,
United States
IVD General
CE/IVDD
GUDID
on market
ACCURUN 121 HAV IgM Positive Control
LGC Clinical Diagnostics, Inc.
·
,
United States
IVD General
CE/IVDD
GUDID
on market
HAV IgM and HEV IgM Multi Control
Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
·
,
China
Class C
CE/IVDR
A51 Hepatitis Multi-Marker
LGC Clinical Diagnostics, Inc.
·
,
United States
IVD General
CE/IVDD
GUDID
on market
Atellica IM Hepatitis A Total Quality Control (aHAVT QC)
Siemens Healthcare Diagnostics Inc.
·
,
United States
Class B
CE/IVDR
ACCURUN 305 Series 400 HCV RNA
LGC Clinical Diagnostics, Inc.
·
,
United States
IVD General
CE/IVDD
GUDID
on market
HEV IgG Control
Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
·
,
China
Class C
CE/IVDR
ACCURUN 121 HAV IgM Positive Control
LGC Clinical Diagnostics, Inc.
·
,
United States
IVD General
CE/IVDD
GUDID
on market
A325 Series 700 HBV DNA
LGC Clinical Diagnostics, Inc.
·
,
United States
IVD General
CE/IVDD
GUDID
on market
A127 Anti-Delta
LGC Clinical Diagnostics, Inc.
·
,
United States
IVD General
CE/IVDD
GUDID
on market
HEV IgG Control
Shenzhen Mindray Bio-Medical Electronics Co., LTD
·
,
China
Class C
CE/IVDR
Atellica IM Quantitative HBsAg Quality Control (QHBs QC)
Siemens Healthcare Diagnostics Products Limited
·
,
United Kingdom
Class C
CE/IVDR
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