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In vitro diagnostic medical devices
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Infectious diseases
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Hepatitis viruses (infect. immunology/nat)
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Hepatitis a virus
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Hav antibody (total)
Hav antibody (total)
W0105020102
18 devices
Devices
VIDAS® Anti-HAV Total
Biomerieux SA
·
,
FR
Class B
CE/IVDR
HAV IgG/IgM Rapid Test Cassette (Whole Blood +2 more)
Healgen Scientific Limited Liability Company
·
,
US
IVD General
CE/IVDD
HAV Ab (Reagent pack)
Beckman Coulter, Inc.
·
,
US
IVD General
CE/IVDD
HAV IgG/IgM Test
Zhejiang Greylynx Biotech Co., Ltd.
·
,
CN
IVD General
CE/IVDD
Rapid HAV IgG/IgM Combo Test Card
Xiamen Boson Biotech Co., Ltd.
·
,
CN
IVD General
CE/IVDD
Anti-HAV Hepatitis A Virus Antibody (CLIA)
Hangzhou Aichek Medical Technology Co., Ltd.
·
,
CN
IVD General
CE/IVDD
HAV IgG/IgM Rapid Test Cassette (Serum/Plasma)
Zhejiang Orient Gene Biotech Co., Ltd.
·
,
CN
IVD General
CE/IVDD
Access anti-HAV IgM
Beckman Coulter, Inc.
·
,
US
Class B
FDA 510(k)
K251995
Active
Cleared 27 Jan 2026
CE/IVDR
Access anti-HAV
Beckman Coulter, Inc.
·
,
US
Class B
CE/MDR
HAV IgG/IgM Rapid Test Cassette (Serum/Plasma)
Healgen Scientific Limited Liability Company
·
,
US
IVD General
CE/IVDD
MAGLUMI Anti-HAV (CLIA)
Shenzhen New Industries Biomedical Engineering Co., Ltd.
·
,
CN
IVD General
CE/IVDD
Atellica IM Hepatitis A Total (aHAVT)
Siemens Healthcare Diagnostics Inc.
·
,
US
Class B
CE/IVDR
Lysun
Hangzhou Lysun Biotechnology Co., Ltd
·
,
CN
IVD General
CE/IVDD
Antibody to Hepatitis A Virus (CLIA)
Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
·
,
CN
Class C
CE/IVDR
Antibody to Hepatitis A Virus (CLIA)
Shenzhen Mindray Bio-Medical Electronics Co., LTD
·
,
CN
Class C
CE/IVDR
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