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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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Controls - inf. immunology - other
Controls - inf. immunology - other
W0105080899
74 devices
Helix Elite™ Molecular Standards: Inactivated Standard
Microbiologics, Inc.
·
,
United States
Class B
CE/IVDR
GUDID
on market
Vigil Serology Control Level C
Beckman Coulter, Inc.
·
,
United States
IVD General
FDA 510(k)
K010358
Active
Cleared 5 Mar 2001
CE/IVDD
HSV-2 IgG Control
Maccura Biotechnology Co., Ltd.
·
,
China
IVD General
CE/IVDD
Kontrola pozytywna Norovirus GI
BioMaxima Spółka Akcyjna
·
,
Poland
Class B
CE/IVDR
ACCURUN 803 Nucleic Acid Negative Quality Control
LGC Clinical Diagnostics, Inc.
·
,
United States
IVD General
CE/IVDD
GUDID
on market
A1 Negative Control
LGC Clinical Diagnostics, Inc.
·
,
United States
IVD General
CE/IVDD
GUDID
on market
SEROLOGY HBeAg POSITIVE CONTROL (HBeAg CONTROL +)
Randox Laboratories Limited
·
,
Northern Ireland
Class B
CE/IVDR
HSV-1/2 IgG Control
Maccura Biotechnology Co., Ltd.
·
,
China
IVD General
CE/IVDD
Polyvalent negative control, 1 x 1 mL
Chronolab Systems, S.L.
·
,
Spain
IVD General
CE/IVDD
ACCURUN 800 ToRCH Negative Control
LGC Clinical Diagnostics, Inc.
·
,
United States
IVD Annex II List B
CE/IVDD
GUDID
on market
Access CMV IgG QC
Beckman Coulter, Inc.
·
,
United States
IVD Annex II List B
CE/IVDD
ACCURUN 40 Anti-Measles, Mumps, Rubella, VZV Positive Control Series 5000
LGC Clinical Diagnostics, Inc.
·
,
United States
IVD Annex II List B
CE/IVDD
GUDID
on market
Multichem ID Multi-Marker Negative Control 2 x 4mL
LGC Clinical Diagnostics, Inc.
·
,
United States
Class B
CE/IVDR
GUDID
on market
Respiratory Antigens Negative Control
BioMaxima Spółka Akcyjna
·
,
Poland
Class B
CE/IVDR
Multichem ID-COVID19 G
Techno-Path Manufacturing
·
,
Ireland
IVD General
CE/IVDD
GUDID
on market
A1 Negative Control
LGC Clinical Diagnostics, Inc.
·
,
United States
IVD General
CE/IVDD
GUDID
on market
Kontrola pozytywna Norovirus GII
BioMaxima Spółka Akcyjna
·
,
Poland
Class B
CE/IVDR
PATHFAST TB LAM Ag Control
Phc Corporation
·
,
Japan
Class C
CE/IVDR
Kontrola pozytywna C. difficile GDH
BioMaxima Spółka Akcyjna
·
,
Poland
Class B
CE/IVDR
Polyvalent positive control, 1 x 1 mL
Chronolab Systems, S.L.
·
,
Spain
IVD General
CE/IVDD
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