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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
Helix Elite™ Molecular Standards: Inactivated Standard
Microbiologics, Inc.
·
,
United States
Class B
CE/IVDR
GUDID
on market
COVID-19 Neutralization Ab Control LQ
NanoEnTek, Inc.
·
,
South Korea
IVD General
CE/IVDD
ACCURUN 873 HPV DNA Negative Control
LGC Clinical Diagnostics, Inc.
·
,
United States
IVD General
CE/IVDD
GUDID
on market
Optitrol Paediatric G-2, 2x pos, 2, 5mL
LGC Clinical Diagnostics, Inc.
·
,
United States
Class B
CE/IVDR
VALIDATE® Anti-SARS-CoV2 IgG Test Set
LGC Clinical Diagnostics, Inc.
·
,
United States
IVD General
CE/IVDD
GUDID
on market
ACCURUN 140 Rubella IgG Positive Control
LGC Clinical Diagnostics, Inc.
·
,
United States
IVD Annex II List B
CE/IVDD
GUDID
on market
Optitrol Paediatric G-2, 1x pos, 1mL
LGC Clinical Diagnostics, Inc.
·
,
United States
Class B
CE/IVDR
QC Sets and Panels: Helix Elite™
Microbiologics, Inc.
·
,
United States
Class B
CE/IVDR
GUDID
on market
ACCURUN Anti-SARS-CoV-2 Series 2000
LGC Clinical Diagnostics, Inc.
·
,
United States
IVD General
CE/IVDD
GUDID
on market
EB EA IgM Control
Shenzhen Yhlo Biotech Co., Ltd.
·
,
China
IVD General
CE/IVDD
Helix Elite™ Molecular Standards: Inactivated Standard
Microbiologics, Inc.
·
,
United States
Class B
CE/IVDR
GUDID
on market
EB NA IgA Control
Shenzhen Yhlo Biotech Co., Ltd.
·
,
China
IVD General
CE/IVDD
ACCURUN 381 HPV Type 16 and 18 mRNA Positive Control
LGC Clinical Diagnostics, Inc.
·
,
United States
IVD General
CE/IVDD
GUDID
on market
Pathodx Herpes Typing Control Slides
Remel Europe Ltd
·
,
United Kingdom
Class C
CE/IVDR
GUDID
on market
QC Sets and Panels: Helix Elite™
Microbiologics, Inc.
·
,
United States
Class B
CE/IVDR
GUDID
on market
Helix Elite™ Molecular Standards: Inactivated Standard
Microbiologics, Inc.
·
,
United States
Class B
CE/IVDR
GUDID
on market
ACCURUN 25 ToRCH IgG Positive Control S2000
LGC Clinical Diagnostics, Inc.
·
,
United States
IVD Annex II List B
CE/IVDD
ACCURUN 372 HPV DNA Positive Control Series 600
LGC Clinical Diagnostics, Inc.
·
,
United States
IVD General
CE/IVDD
GUDID
on market
ACCURUN 141 Rubella IgM Positive Control
LGC Clinical Diagnostics, Inc.
·
,
United States
IVD Annex II List B
CE/IVDD
GUDID
on market
ACCURUN 31 EBV IgM Positive Control
LGC Clinical Diagnostics, Inc.
·
,
United States
IVD General
CE/IVDD
GUDID
on market
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