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Results for “BCL-6”
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EUDAMED
8
FDA 510(k) incl. De Novo
FDA PMA
GUDID
11
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8
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11
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6
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1
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1
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4
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8
IVD Annex II List A
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IVD for self-testing
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4 devices found
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Verified
Verified
Status
Status
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Regime
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Registry
Class
Class
Calprotectin & Lactoferrin Test
Bi-trumed Biotech Co., Ltd.
·
,
China
Group of variants
CE/IVDD
Active
Regimes:
CE IVDD
Registry:
EUDAMED
Class
Class:
IVD General
b.clean
Alpro Medical GmbH
·
,
Germany
CE/MDR
Active
Regimes:
CE MDR
Registry:
EUDAMED
Class
Class:
IIa
Chloride Reagent Kit
Hangzhou Aichek Medical Technology Co., Ltd.
·
,
China
CE/IVDD
Active
Regimes:
CE IVDD
Registry:
EUDAMED
Class
Class:
IVD General
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