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12 devices found
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Manufacturer: Curetis GmbH
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Device · Manufacturer · Authorizations
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Class
Acuitas QIAGEN® EZ1® Advanced XL System
Curetis GmbH
·
,
Germany
(FDA 510(k) applicant)
Class II
GUDID
not on market
Withdrawn
GUDID
II
Acuitas
Curetis GmbH
·
,
Germany
(FDA 510(k) applicant)
Class II
GUDID
not on market
Withdrawn
GUDID
II
Unyvero LRT BAL Cartridge Kit
Curetis GmbH
·
,
Germany
(FDA 510(k) applicant)
Class II
GUDID
not on market
Withdrawn
GUDID
II
Acuitas AMR Gene Panel PCR Plate Kit
Curetis GmbH
·
,
Germany
(FDA 510(k) applicant)
Class II
GUDID
not on market
Withdrawn
GUDID
II
Acuitas AMR Gene Panel Reagent Kit
Curetis GmbH
·
,
Germany
(FDA 510(k) applicant)
Class II
GUDID
not on market
Withdrawn
GUDID
II
Unyvero A50 Analyzer
Curetis GmbH
·
,
Germany
(FDA 510(k) applicant)
Class II
GUDID
not on market
Withdrawn
GUDID
II
Unyvero LRT Cartridge Kit
Curetis GmbH
·
,
Germany
(FDA 510(k) applicant)
Class II
GUDID
not on market
Withdrawn
GUDID
II
Unyvero L4 Lysator
Curetis GmbH
·
,
Germany
(FDA 510(k) applicant)
Class II
GUDID
not on market
Withdrawn
GUDID
II
Unyvero M1 Master Mix Tube Kit
Curetis GmbH
·
,
Germany
(FDA 510(k) applicant)
Class II
GUDID
not on market
Withdrawn
GUDID
II
Unyvero C8 Cockpit
Curetis GmbH
·
,
Germany
(FDA 510(k) applicant)
Class II
GUDID
not on market
Withdrawn
GUDID
II
Unyvero LRT BAL Application
Curetis GmbH
·
,
Germany
(FDA 510(k) applicant)
Class II
FDA 510(k)
K191967
Active
Cleared 20 Dec 2019
Active
510(k)
510(k)
II
Curetis Unyvero LRT Application
Curetis GmbH
·
,
Germany
(FDA 510(k) applicant)
Class II
FDA De Novo
DEN170047
Active
Cleared 3 Apr 2018
FDA 510(k)
Active
De Novo
510(k)
II
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