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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
Healgen Scientific Limited Liability Company
·
,
United States
IVD General
CE/IVDD
Serology Ii Positive Control (Serology Ii Control Positive)
Randox Laboratories Limited
·
,
Northern Ireland
Class B
CE/IVDR
GUDID
on market
Optitrol HEPA-1, 1x pos, 1mL
LGC Clinical Diagnostics, Inc.
·
,
United States
Class B
CE/IVDR
RIDA®Plex Positive Control Bacteria and Resistances
AusDiagnostics Pty Ltd
·
,
Australia
IVD General
CE/IVDD
SEROLOGY ToRCH NEGATIVE CONTROL (ToRCH CONTROL -)
Randox Laboratories Limited
·
,
Northern Ireland
Class B
CE/IVDR
GUDID
on market
Optitrol HEPA-2, 2x pos, 2.5mL
LGC Clinical Diagnostics, Inc.
·
,
United States
Class B
CE/IVDR
Optitrol Yellow, 1x pos, 1mL
LGC Clinical Diagnostics, Inc.
·
,
United States
Class B
CE/IVDR
ACCURUN 345 HIV-1 RNA, HCV RNA, HBV DNA Positive Quality Control Series 150
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 HIV 2, 2x pos, 2.5mL
LGC Clinical Diagnostics, Inc.
·
,
United States
Class B
CE/IVDR
Synthetic Positive Controls for Faecal Panels
AusDiagnostics Pty Ltd
·
,
Australia
IVD General
CE/IVDD
ToRCH IgM Positive Control
Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
·
,
China
Class C
CE/IVDR
A21 Series 1000 CE
LGC Clinical Diagnostics, Inc.
·
,
United States
IVD General
CE/IVDR
CE/IVDD
+1
authorizations
ACCURUN 345 HIV-1 RNA, HCV RNA, HBV DNA Positive Quality Control Series 150
LGC Clinical Diagnostics, Inc.
·
,
United States
IVD General
CE/IVDD
GUDID
on market
Synthetic Positive Controls for STIs and Herpes
AusDiagnostics Pty Ltd
·
,
Australia
IVD Annex II List B
CE/IVDD
Optitrol SeroNeg, 2x neg, 1mL
LGC Clinical Diagnostics, Inc.
·
,
United States
Class B
CE/IVDR
Optitrol HEPR-2, 2x pos, 2.5mL
LGC Clinical Diagnostics, Inc.
·
,
United States
Class B
CE/IVDR
GUDID
on market
A1 Series 4400
LGC Clinical Diagnostics, Inc.
·
,
United States
IVD General
CE/IVDD
GUDID
on market
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