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In vitro diagnostic medical devices
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Controls/standards/calibrators - (infect. immunology/nat)
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Controls - infect. immunology
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Multiconstituent controls - inf.imm.
Multiconstituent controls - inf.imm.
W0105080807
124 devices
ToRCH IgM Positive Control
Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
·
,
China
Class C
CE/IVDR
Optitrol Yellow 4x5 mL
LGC Clinical Diagnostics, Inc.
·
,
United States
Class B
CE/IVDR
Optitrol HIV p24, 4x pos, 2.5mL
LGC Clinical Diagnostics, Inc.
·
,
United States
Class B
CE/IVDR
Synthetic Positive Controls for Atypical Pneumonia
AusDiagnostics Pty Ltd
·
,
Australia
IVD Annex II List B
CE/IVDD
A21 Series 2000 CE
LGC Clinical Diagnostics, Inc.
·
,
United States
IVD General
CE/IVDD
QC Sets and Panels: Helix Elite™
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
Optitrol SeroNeg, 4x neg, 1mL
LGC Clinical Diagnostics, Inc.
·
,
United States
Class B
CE/IVDR
Optitrol Blue
LGC Clinical Diagnostics, Inc.
·
,
United States
Class B
CE/IVDR
GUDID
on market
Optitrol Orange, 1x pos, 1mL
LGC Clinical Diagnostics, Inc.
·
,
United States
Class B
CE/IVDR
ToRCH IgG Control
Autobio Diagnostics Co., Ltd.
·
,
China
Class C
CE/IVDR
Serology Negative Control (Serology Control Negative)
Randox Laboratories Limited
·
,
Northern Ireland
Class B
CE/IVDR
GUDID
on market
Accurun 1 Series 5100 Positive Control
LGC Clinical Diagnostics, Inc.
·
,
United States
IVD General
CE/IVDD
GUDID
on market
ToRCH IgM Control
Autobio Diagnostics Co., Ltd.
·
,
China
Class C
CE/IVDR
ToRCH IgG Control
Autobio Diagnostics Co., Ltd.
·
,
China
Class C
CE/IVDR
Serology Lyme Disease Negative Control (Lyme Control -)
Randox Laboratories Limited
·
,
Northern Ireland
Class B
CE/IVDR
GUDID
on market
Optitrol Blue
LGC Clinical Diagnostics, Inc.
·
,
United States
Class B
CE/IVDR
GUDID
on market
A1 Series 2400
LGC Clinical Diagnostics, Inc.
·
,
United States
IVD General
CE/IVDD
GUDID
on market
RIDA®Plex Positive Control Faecal Pathogens
AusDiagnostics Pty Ltd
·
,
Australia
IVD General
CE/IVDD
Optitrol Red, 4x pos, 5mL
LGC Clinical Diagnostics, Inc.
·
,
United States
Class B
CE/IVDR
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