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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
Optitrol Mumps M, 2x pos, 1mL
LGC Clinical Diagnostics, 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
QC Sets and Panels: Helix Elite™
Microbiologics, Inc.
·
,
United States
Class B
CE/IVDR
GUDID
on market
EB VCA IgG Control
Shenzhen Yhlo Biotech Co., Ltd.
·
,
China
IVD General
CE/IVDD
Rubella IgM Control
Shenzhen Yhlo Biotech Co., Ltd.
·
,
China
Class C
CE/IVDR
COVID-19 SP Control LQ
NanoEnTek, Inc.
·
,
South Korea
IVD General
CE/IVDD
ACCURUN 30 EBV IgG Positive Control
LGC Clinical Diagnostics, Inc.
·
,
United States
IVD General
CE/IVDD
GUDID
on market
QC Sets and Panels: Helix Elite™
Microbiologics, Inc.
·
,
United States
Class B
CE/IVDR
GUDID
on market
HSV-2 IgG Control
Shenzhen Yhlo Biotech Co., Ltd.
·
,
China
IVD General
CE/IVDD
RSV Antigen Control Kit
Healgen Scientific Limited Liability Company
·
,
United States
IVD General
CE/IVDD
HSV-1 IgG Control
Shenzhen Yhlo Biotech Co., Ltd.
·
,
China
IVD General
CE/IVDD
ACCURUN 372 HPV DNA Positive Control Series 400
LGC Clinical Diagnostics, Inc.
·
,
United States
IVD General
CE/IVDD
GUDID
on market
Optitrol Paediatric G negative, 2x neg, 2, 5mL
LGC Clinical Diagnostics, Inc.
·
,
United States
Class B
CE/IVDR
ACCURUN 378 HPV DNA Positive Control Series 5000
LGC Clinical Diagnostics, Inc.
·
,
United States
IVD General
CE/IVDD
GUDID
on market
EB NA IgG Control
Shenzhen Yhlo Biotech Co., Ltd.
·
,
China
IVD General
CE/IVDD
Adenovirus Antigen FIA Control Kit
Healgen Scientific Limited Liability Company
·
,
United States
IVD General
CE/IVDD
ACCURUN 26 ToRC IgM Positive Control Series 5000
LGC Clinical Diagnostics, Inc.
·
,
United States
IVD Annex II List B
CE/IVDD
GUDID
on market
ACCURUN 145 CMV IgG Positive Control
LGC Clinical Diagnostics, Inc.
·
,
United States
IVD Annex II List B
CE/IVDD
GUDID
on market
Adenovirus Antigen Control Kit
Zhejiang Orient Gene Biotech Co., Ltd.
·
,
China
IVD General
CE/IVDD
Rubella IgG Control
Shenzhen Yhlo Biotech Co., Ltd.
·
,
China
Class C
CE/IVDR
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