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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
GeneProof Universal Internal Control
GeneProof a.s.
·
,
Czechia
Class B
CE/IVDR
Rotavirus and Adenovirus Antigen Control Kit
Zhejiang Orient Gene Biotech Co., Ltd.
·
,
China
IVD General
CE/IVDD
A1 Series 4000
LGC Clinical Diagnostics, Inc.
·
,
United States
IVD General
CE/IVDD
GUDID
on market
RIDA®Plex Positive Control Fungal Panels
AusDiagnostics Pty Ltd
·
,
Australia
IVD General
CE/IVDD
QC Sets and Panels: Helix Elite™
Microbiologics, Inc.
·
,
United States
Class B
CE/IVDR
GUDID
on market
ToRCH IgG/IgM Negative Control
Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
·
,
China
Class C
CE/IVDR
ToRCH IgM Control
Autobio Diagnostics Co., Ltd.
·
,
China
Class C
CE/IVDR
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 I Positive Control (Serology I Control Positive)
Randox Laboratories Limited
·
,
Northern Ireland
Class B
CE/IVDR
GUDID
on market
Optitrol Red, 2x pos, 5mL
LGC Clinical Diagnostics, Inc.
·
,
United States
Class B
CE/IVDR
ToRCH IgM Positive Control
Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
·
,
China
Class C
CE/IVDR
RIDA®Plex Positive Control CSF
AusDiagnostics Pty Ltd
·
,
Australia
IVD Annex II List B
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 Orange, 4x pos, 5mL
LGC Clinical Diagnostics, Inc.
·
,
United States
Class B
CE/IVDR
Optitrol Yellow, 2x pos, 5mL
LGC Clinical Diagnostics, Inc.
·
,
United States
Class B
CE/IVDR
Optitrol HEPA-2, 1x pos, 1mL
LGC Clinical Diagnostics, Inc.
·
,
United States
Class B
CE/IVDR
Optitrol HEPA-1, 2x pos, 2.5mL
LGC Clinical Diagnostics, Inc.
·
,
United States
Class B
CE/IVDR
ToRCH IgM Control
Autobio Diagnostics Co., Ltd.
·
,
China
Class C
CE/IVDR
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