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In vitro diagnostic medical devices
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Infectious diseases
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Controls/standards/calibrators - (infect. immunology/nat)
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Controls - infect. immunology
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Parasitology controls - inf.imm.
Parasitology controls - inf.imm.
W0105080805
19 devices
Devices
Toxo IgG Avidity Control
Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
·
,
CN
Class C
CE/IVDR
Toxo IgG Avidity Control
Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
·
,
CN
Class C
CE/IVDR
Toxo IgG Avidity Control
Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
·
,
CN
Class C
CE/IVDR
Helix Elite™ Molecular Standards: Inactivated Standard
Microbiologics, Inc.
·
,
US
Class B
CE/IVDR
GUDID
on market
ACCURUN 135 Toxoplasma IgG Positive Control
LGC Clinical Diagnostics, Inc.
·
,
US
IVD Annex II List B
CE/IVDD
GUDID
on market
ACCURUN 132 Borrelia burgdorferi IgM Positive Control
LGC Clinical Diagnostics, Inc.
·
,
US
IVD General
CE/IVDD
GUDID
on market
Toxo IgG Avidity Control
Shenzhen Mindray Bio-Medical Electronics Co., LTD
·
,
CN
Class C
CE/MDR
Control positivo en seco Crypto-Giardia-Entamoeba / Crypto-Giardia-Entamoeba Dr…
Operon, S.A.
·
,
ES
Class B
CE/IVDR
Toxo IgG Avidity Control
Shenzhen Mindray Bio-Medical Electronics Co., LTD
·
,
CN
Class C
CE/MDR
MALARIA Control
Biosynex
·
,
FR
IVD General
CE/IVDD
Aptima Trichomonas vaginalis Controls Kit
Hologic
·
,
US
Class C
CE/IVDR
GUDID
on market
ACCURUN 190 Chagas Positive Control
LGC Clinical Diagnostics, Inc.
·
,
US
IVD General
CE/IVDD
GUDID
on market
ACCURUN Babesia Molecular Controls Kit
LGC Clinical Diagnostics, Inc.
·
,
US
Class B
CE/IVDR
GUDID
on market
ACCURUN 136 Toxoplasma IgM Positive Control
LGC Clinical Diagnostics, Inc.
·
,
US
IVD Annex II List B
CE/IVDD
GUDID
on market
Toxo IgG Avidity Control
Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
·
,
CN
Class C
CE/IVDR
Toxo IgG Avidity Control
Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
·
,
CN
Class C
CE/IVDR
Toxo IgG Avidity Control
Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
·
,
CN
Class C
CE/IVDR
QC Sets and Panels: Helix Elite™
Microbiologics, Inc.
·
,
US
Class B
CE/IVDR
GUDID
on market
Toxo IgM Control
Shenzhen Yhlo Biotech Co., Ltd.
·
,
CN
Class C
CE/IVDR
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