324 results · 28ms · Sources: EU EUDAMED, US FDA

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Hemoglobin A1c Control Set

Basic UDI-DI
EU IVDR · Eu Ivd Class C ·Tosoh Corporation·1 device

Hemoglobin A1c Calibrator Set

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EU IVDR · Eu Ivd Class C ·Tosoh Corporation·3 devices

D-Dimer Calibration Set

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EU IVDR · Eu Ivd Class C ·Thermo Fisher Scientific Oy·1 device

Flow Set Pro Fluorospheres

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EU IVDR · Eu Ivd Class C ·Beckman Coulter Ireland Inc.·1 device

CRP Latex Calibrator Normal Set

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EU IVDR · Eu Ivd Class C ·Beckman Coulter Inc.·1 device

CRP Latex Calibrator Highly Sensitive Set

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EU IVDR · Eu Ivd Class C ·Beckman Coulter Inc.·1 device

LYNOAMP CK19 E

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EU IVDR · Eu Ivd Class C ·SYSMEX CORPORATION·1 device

P53 (TP53)/ATM Combination Deletion Probe

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EU IVDR · Eu Ivd Class C ·Cytocell Limited·2 devices

EVI1 (MECOM) Breakapart Probe

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EU IVDR · Eu Ivd Class C ·Cytocell Limited·2 devices

Del(5q) Deletion Probe

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EU IVDR · Eu Ivd Class C ·Cytocell Limited·2 devices

Del(20q) Deletion Probe

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EU IVDR · Eu Ivd Class C ·Cytocell Limited·2 devices

Del(7q) Deletion Probe

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EU IVDR · Eu Ivd Class C ·Cytocell Limited·2 devices

CBFß (CBFB)/MYH11 Translocation, Dual Fusion Probe

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EU IVDR · Eu Ivd Class C ·Cytocell Limited·2 devices

CBFB Breakapart Probe

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EU IVDR · Eu Ivd Class C ·Cytocell Limited·2 devices

BCR/ABL (ABL1) Plus Translocation, Dual Fusion Probe

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EU IVDR · Eu Ivd Class C ·Cytocell Limited·2 devices

IGH/MAF Plus v2 Translocation, Dual Fusion Probe

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EU IVDR · Eu Ivd Class C ·Cytocell Limited·2 devices

FAST PML/RARα (RARA) Translocation, Dual Fusion Probe

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EU IVDR · Eu Ivd Class C ·Cytocell Limited·2 devices

CKS1B/CDKN2C (P18) Amplification/Deletion Probe

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EU IVDR · Eu Ivd Class C ·Cytocell Limited·2 devices

AML1 (RUNX1) Breakapart Probe

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EU IVDR · Eu Ivd Class C ·Cytocell Limited·2 devices

AML1/ETO (RUNX1/RUNX1T1) Translocation, Dual Fusion Probe

Basic UDI-DI
EU IVDR · Eu Ivd Class C ·Cytocell Limited·2 devices