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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
QC Sets and Panels: Helix Elite™
Microbiologics, Inc.
·
,
United States
Class B
CE/IVDR
GUDID
on market
Serology Lyme Disease Posititve Control (Lyme Control +)
Randox Laboratories Limited
·
,
Northern Ireland
Class B
CE/IVDR
GUDID
on market
RIDA®Plex Positive Control STIs and Herpes
AusDiagnostics Pty Ltd
·
,
Australia
IVD Annex II List B
CE/IVDD
Optitrol HIV 2, 1x pos, 1mL
LGC Clinical Diagnostics, Inc.
·
,
United States
Class B
CE/IVDR
A1 Series 2700
LGC Clinical Diagnostics, Inc.
·
,
United States
IVD General
CE/IVDD
GUDID
on market
Accurun 2 Series 2700
LGC Clinical Diagnostics, Inc.
·
,
United States
IVD General
CE/IVDD
Optitrol Orange, 2x pos, 5mL
LGC Clinical Diagnostics, Inc.
·
,
United States
Class B
CE/IVDR
Specific Proteins Multiconstituent Control
Shenzhen AmTech Bioengineering Ltd., Inc.
·
,
China
IVD General
CE/IVDD
Synthetic Positive Controls for Fungal Panels
AusDiagnostics Pty Ltd
·
,
Australia
IVD General
CE/IVDD
ToRCH IgG/IgM Negative Control
Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
·
,
China
Class C
CE/IVDR
SEROLOGY ToRCH IgG POSITIVE CONTROL (ToRCH IgG CONTROL +)
Randox Laboratories Limited
·
,
Northern Ireland
Class B
CE/IVDR
GUDID
on market
ToRCH IgG Control
Autobio Diagnostics Co., Ltd.
·
,
China
Class C
CE/IVDR
Panther Fusion AdV/hMPV/RV Assay Controls Kit
Hologic
·
,
United States
Class B
CE/IVDR
GUDID
on market
SEROLOGY ToRCH IgM POSITIVE CONTROL (ToRCH IgM CONTROL +)
Randox Laboratories Limited
·
,
Northern Ireland
Class B
CE/IVDR
GUDID
on market
Optitrol HEPR-2, 1x pos, 1mL
LGC Clinical Diagnostics, Inc.
·
,
United States
Class B
CE/IVDR
GUDID
on market
Serology Iii Positive Control (Serology Iii Control Positive)
Randox Laboratories Limited
·
,
Northern Ireland
Class B
CE/IVDR
GUDID
on market
Synthetic Positive Controls for HPV
AusDiagnostics Pty Ltd
·
,
Australia
IVD General
CE/IVDD
ToRCH IgG Positive Control
Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
·
,
China
Class C
CE/IVDR
A1 Series 5600
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
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