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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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Other virology controls - inf.imm.
Other virology controls - inf.imm.
W0105080804
85 devices
Devices
ACCURUN Anti-SARS-CoV-2 IgM Controls Kit
LGC Clinical Diagnostics, Inc.
·
,
US
IVD General
CE/IVDD
GUDID
on market
Optitrol Mumps M, 1x pos, 1mL
LGC Clinical Diagnostics, Inc.
·
,
US
Class B
CE/IVDR
EB VCA IgA Control
Shenzhen Yhlo Biotech Co., Ltd.
·
,
CN
IVD General
CE/IVDD
RSV Antigen Control Kit
Healgen Scientific Limited Liability Company
·
,
US
IVD General
CE/IVDD
Imagen Hsv Positive Control Slide
Oxoid Ltd
·
,
GB
Class C
CE/IVDR
ACCURUN 146 CMV IgM Positive Control
LGC Clinical Diagnostics, Inc.
·
,
US
IVD Annex II List B
CE/IVDD
GUDID
on market
Helix Elite™ Molecular Standards: Inactivated Standard
Microbiologics, Inc.
·
,
US
Class B
CE/IVDR
GUDID
on market
RSV Antigen FIA Control Kit
Healgen Scientific Limited Liability Company
·
,
US
IVD General
CE/IVDD
Helix Elite™ Molecular Standards: Inactivated Standard
Microbiologics, Inc.
·
,
US
Class B
CE/IVDR
GUDID
on market
ACCURUN 156 Reagin (Syphilis) Positive Control
LGC Clinical Diagnostics, Inc.
·
,
US
IVD General
CE/IVDD
GUDID
on market
Multichem ID Rubella IgM Positive Control
LGC Clinical Diagnostics, Inc.
·
,
US
IVD Annex II List B
CE/IVDD
GUDID
on market
HSV-1 IgM Control
Shenzhen Yhlo Biotech Co., Ltd.
·
,
CN
IVD General
CE/IVDD
Optitrol Chagas-1, 2x pos, 2.5mL
LGC Clinical Diagnostics, Inc.
·
,
US
Class B
CE/IVDR
Helix Elite™ Molecular Standards: Inactivated Standard
Microbiologics, Inc.
·
,
US
Class B
CE/IVDR
GUDID
on market
Control Positivo En Seco Rota-Adeno-Noro || Dry Positive Control Rota-Adeno-Noro
Operon, S.A.
·
,
ES
Class B
CE/IVDR
Multichem ID ToRCH IgG Positive Control
LGC Clinical Diagnostics, Inc.
·
,
US
IVD Annex II List B
CE/IVDD
GUDID
on market
ACCURUN 25 ToRCH IgG Positive Control S5000
LGC Clinical Diagnostics, Inc.
·
,
US
IVD Annex II List B
CE/IVDD
GUDID
on market
Helix Elite™ Molecular Standards: Inactivated Standard
Microbiologics, Inc.
·
,
US
Class B
CE/IVDR
GUDID
on market
Multichem ID ToRC IgM Positive Control
LGC Clinical Diagnostics, Inc.
·
,
US
IVD Annex II List B
CE/IVDD
GUDID
on market
Helix Elite™ Molecular Standards: Inactivated Standard
Microbiologics, Inc.
·
,
US
Class B
CE/IVDR
GUDID
on market
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