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In vitro diagnostic medical devices
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Infectious diseases
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Infectious immunology - rapid tests & point of care
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Controls, standards and calibrators infectious immunology - rt & poc
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Controls infectious immunology - rt & poc
Controls infectious immunology - rt & poc
W0105094001
54 devices
Devices
INSTI HIV-1/HIV-2 Test Controls
Biolytical Laboratories Inc.
·
,
CA
IVD Annex II List A
CE/IVDD
BIOHIT 𝘏𝘦𝘭𝘪𝘤𝘰𝘣𝘢𝘤𝘵𝘦𝘳 𝘱𝘺𝘭𝘰𝘳𝘪 Control
Biohit Oyj
·
,
FI
IVD General
CE/IVDD
biotical E. Coli Positive control (30u)
Biotical Health S.L.U
·
,
ES
IVD General
CE/IVDD
biotical C. difficile GDH Positive control (30u)
Biotical Health S.L.U
·
,
ES
IVD General
CE/IVDD
Monkeypox Virus (MPxV) Antigen Quality Control
Shenzhen Superbio Technology Co., Ltd.
·
,
CN
IVD General
CE/IVDD
biotical S. paratyphi Positive control (1u)
Biotical Health S.L.U
·
,
ES
IVD General
CE/IVDD
Positive control swab Adenovirus & Rotavirus
BIOSYNEX Swiss SA
·
,
CH
IVD General
CE/IVDD
biotical Campylobacter Positive control (30u)
Biotical Health S.L.U
·
,
ES
IVD General
CE/IVDD
biotical Norovirus Gen I Positive control (30u)
Biotical Health S.L.U
·
,
ES
IVD General
CE/IVDD
biotical Enterovirus Positive Control (1u)
Biotical Health S.L.U
·
,
ES
IVD General
CE/IVDD
biotical Salmonella Positive control (30u)
Biotical Health S.L.U
·
,
ES
IVD General
CE/IVDD
COVID-19 IgG/IgM CONTROL Kit
Zhejiang Orient Gene Biotech Co., Ltd.
·
,
CN
IVD General
CE/IVDD
COVID-19 Antigen Control Kit
Healgen Scientific Limited Liability Company
·
,
US
IVD General
CE/IVDD
SARS-CoV-2/Influenza A/Influenza B/RSV Nucleic Acid Assay Control
Guangzhou Pluslife Biotech Co., Ltd
·
,
CN
IVD General
CE/IVDD
COVID-19 Antigen Control Kit
Zhejiang Orient Gene Biotech Co., Ltd.
·
,
CN
IVD General
CE/IVDD
biotical Y. enterocolitica O:9 Positive control (30u)
Biotical Health S.L.U
·
,
ES
IVD General
CE/IVDD
biotical C. difficile Toxin A Positive control (30u)
Biotical Health S.L.U
·
,
ES
IVD General
CE/IVDD
biotical Norovirus Gen II Positive control (30u)
Biotical Health S.L.U
·
,
ES
IVD General
CE/IVDD
S. pneumoniae/L. pneumophila Control
Newlink Biotech co., Ltd.
·
,
CN
IVD General
CE/IVDD
Monkeypox Virus (MPxV) Antigen Quality Control
Shenzhen Superbio Technology Co., Ltd.
·
,
CN
IVD General
CE/IVDD
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