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Controls/standards/calibrators - (infect. immunology/nat)
Controls/standards/calibrators - (infect. immunology/nat)
W010508
771 devices
Subcategories
2
W01050808
Controls - infect. immunology
743
devices
›
W01050809
Standards and calibrators - infect. immunology/nat
28
devices
›
Devices
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
Amplirun® Parainfluenza 2 Rna Control
Vircell, S.L
·
,
Spain
Class B
CE/IVDR
PoET Internal Control
Gesellschaft zur Forschung, Entwicklung und Distribution von Diagnostika im Blutspendewesen mbH
·
,
Germany
IVD General
CE/IVDD
GeneStream Dengue Virus Typing1, 2, 3, 4 Controls
Hangzhou Danwei Biotechnology Co., Ltd
·
,
China
IVD General
CE/IVDD
VitaPCR SARS-CoV-2 External Control Set
Credo Diagnostics Biomedical Pte. Ltd. Taiwan Branch
·
,
Taiwan
IVD General
CE/IVDD
REDx SARS-CoV-2 Positive Control
Microbix Biosystems Inc.
·
,
Canada
Class B
CE/IVDR
GeneStream MTB MDR Controls
Hangzhou Danwei Biotechnology Co., Ltd
·
,
China
IVD General
CE/IVDD
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