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Controls/standards/calibrators - (infect. immunology/nat)
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Controls - infect. immunology
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Hepatitis virus controls - inf.imm.
Hepatitis virus controls - inf.imm.
W0105080802
39 devices
Devices
ACCURUN 119 Anti-Hepatitis B e Antigen (Anti-HBe) Positive Control
LGC Clinical Diagnostics, Inc.
·
,
US
IVD General
FDA 510(k)
K972307
Active
Cleared 7 Aug 1997
CE/IVDD
+1
authorizations
ACCURUN 120 Anti-HAV IgG
LGC Clinical Diagnostics, Inc.
·
,
US
IVD General
CE/IVDD
GUDID
on market
ACCURUN 305 Series 100 HCV RNA
LGC Clinical Diagnostics, Inc.
·
,
US
IVD General
CE/IVDD
GUDID
on market
ACCURUN 305 Series 300 HCV RNA
LGC Clinical Diagnostics, Inc.
·
,
US
IVD General
CE/IVDD
GUDID
on market
HAV IgM and HEV IgM Multi Control
Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
·
,
CN
Class C
CE/IVDR
Access anti-HAV IgM QC
Beckman Coulter, Inc.
·
,
US
Class B
CE/IVDR
Anti-HAV Control
Shenzhen Mindray Bio-Medical Electronics Co., LTD
·
,
CN
Class C
CE/IVDR
HAV IgM and HEV IgM Multi Control
Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
·
,
CN
Class C
CE/IVDR
ACCURUN117 Hepatitis B e Antigen Positive Control
LGC Clinical Diagnostics, Inc.
·
,
US
IVD General
CE/IVDD
GUDID
on market
ACCURUN 125 Anti-HBs Positive Control
LGC Clinical Diagnostics, Inc.
·
,
US
IVD General
CE/IVDD
GUDID
on market
Multichem ID HAV IgM Positive Control
LGC Clinical Diagnostics, Inc.
·
,
US
Class B
CE/IVDR
GUDID
on market
A113 Anti-HBc IgM
LGC Clinical Diagnostics, Inc.
·
,
US
IVD General
CE/IVDD
GUDID
on market
HEV IgG Control
Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
·
,
CN
Class C
CE/IVDR
ACCURUN 51 Multi-Marker Hepatitis Positive Control 1 Series 3000
LGC Clinical Diagnostics, Inc.
·
,
US
IVD General
CE/IVDD
HAV IgM and HEV IgM Multi Control
Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
·
,
CN
Class C
CE/IVDR
HEV IgG Control
Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
·
,
CN
Class C
CE/IVDR
A325 Series 200 HBV DNA
LGC Clinical Diagnostics, Inc.
·
,
US
IVD General
CE/IVDD
GUDID
on market
Access anti-HAV QC
Beckman Coulter, Inc.
·
,
US
Class B
FDA 510(k)
K243846
Active
Cleared 9 Sep 2025
CE/IVDR
Anti-HAV Control
Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
·
,
CN
Class C
CE/IVDR
ACCURUN 305 Series 150 HCV RNA Positive Control
LGC Clinical Diagnostics, Inc.
·
,
US
IVD General
CE/IVDD
GUDID
on market
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