356 results · 8ms · Sources: EU EUDAMED, US FDA

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Blueprint Genetics CES Platform

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EU IVDD · Eu Ivd General ·Blueprint Genetics Oy·1 device

Human Epididymal Protein 4(CLIA) 、HE-4 Calibrators

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EU IVDR · Eu Ivd Class C ·Shenzhen Mindray Bio-Medical Electronics Co., Ltd.·3 devices

CQI ABO-D - RH.K - CONTRÔLE QUALITÉ INTERNE POUR LA DÉTERMINATION DES GROUPES SANGUINS DANS LES SYSTÈMES ABO RHÉSUS KELL- BLISTER (EFS)

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EU IVDD · Eu Ivd Annex 2 List A ·ETABLISSEMENT FRANCAIS DU SANG·1 device

CQI ABO-D - Rh.K - Contrôle Qualité Interne pour la détermination des groupes sanguins dans les systèmes ABO Rhésus Kell - Blister (grifols)

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EU IVDD · Eu Ivd Annex 2 List A ·ETABLISSEMENT FRANCAIS DU SANG·1 device

Trousse NG-Mix Multiloci pour le génotypage des allèles HLA en haute résolution par la méthode Nouvelle Génération de Séquençage (NGS)

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EU IVDD · Eu Ivd Annex 2 List B ·ETABLISSEMENT FRANCAIS DU SANG·1 device

STA® - Coag Control N + P

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EU IVDR · Eu Ivd Class C ·Diagnostica Stago·1 device

MULTI-SYSTEM Hb A1c CAPILLARY CONTROLS (10x2)

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EU IVDR · Eu Ivd Class C ·sebia·2 devices

Hb A1c CAPILLARY CALIBRATORS (2)

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EU IVDR · Eu Ivd Class C ·sebia·2 devices

mAbXmise – Anti-drug antibodies quantification Kit multiplex ANTI-Infliximab & ANTI-Adalimumab

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EU IVDR · Eu Ivd Class B ·Promise proteomics·1 device

sthemO Pool Norm

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EU IVDR · Eu Ivd Class B ·Diagnostica Stago·1 device

sthemO XI

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EU IVDR · Eu Ivd Class B ·Diagnostica Stago·1 device

sthemO FVII QC

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EU IVDR · Eu Ivd Class B ·Diagnostica Stago·1 device

sthemO VII

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EU IVDR · Eu Ivd Class B ·Diagnostica Stago·1 device

Stem-Trol Control Cells

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EU IVDR · Eu Ivd Class C ·IMMUNOTECH SAS ·1 device

AQUIOS STEM CD34 Control Cells

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EU IVDR · Eu Ivd Class C ·IMMUNOTECH SAS ·1 device

STA® - FM Calibrator

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EU IVDR · Eu Ivd Class B ·Diagnostica Stago·1 device

STA® - Deficient IX

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EU IVDR · Eu Ivd Class B ·Diagnostica Stago·1 device

STA® - Quality HBPM/LMWH

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EU IVDR · Eu Ivd Class C ·Diagnostica Stago·1 device

ACCURUN 141 Rubella IgM Positive Control

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EU IVDD · Eu Ivd Annex 2 List B ·LGC Clinical Diagnostics, Inc.·1 device

Multichem ID Rubella IgM Positive Control

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EU IVDD · Eu Ivd Annex 2 List B ·LGC Clinical Diagnostics, Inc.·1 device