37 results · 15ms · Sources: EU EUDAMED, US FDA

ALK (QR017)

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EU IVDR · Eu Ivd Class C ·biocyc Biotechnologie GmbH & Co. KG·7 devices

CEP XY, HER2/neu, UroVysion, ALK

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EU IVDD · Eu Ivd General ·Applied Spectral Imaging Ltd·1 device

AmoyDx® EML4-ALK Fusion Gene Detection Kit

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EU IVDD · Eu Ivd General ·Amoy Diagnostics Co., LTD.·1 device

AmoyDx® ALK Gene Fusions and ROS1 Gene Fusions Detection Kit

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EU IVDD · Eu Ivd General ·Amoy Diagnostics Co., LTD.·1 device

AmoyDx® ALK Gene Fusions and ROS1 Gene Fusions Detection Kit

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EU IVDD · Eu Ivd General ·Amoy Diagnostics Co., LTD.·1 device

AmoyDx® ALK Gene Fusions and ROS1 Gene Fusions Detection Kit

Basic UDI-DI
EU IVDD · Eu Ivd General ·Amoy Diagnostics Co., LTD.·1 device

CellSolutions 30

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EU IVDD · Eu Ivd General ·CellSolutions LLC·1 device

CellSolutions F50

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EU IVDD · Eu Ivd General ·CellSolutions LLC·1 device

NATtrol™ Chlamydia trachomatis Positive Control Pack

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EU IVDR · Eu Ivd Class B ·ZeptoMetrix LLC·17 devices

Osmometer Accessories

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EU IVDR · Eu Ivd Class A ·Advanced Instruments, LLC·3 devices

NOVEOS® Immunoassay System Accessories

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EU IVDR · Eu Ivd Class A ·Hycor Biomedical LLC·12 devices

NOVEOS® Immunoassay System

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EU IVDR · Eu Ivd Class A ·Hycor Biomedical LLC·2 devices

KOVA Plastics Urinalysis System

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EU IVDR · Eu Ivd Class A ·Alltrista Plastics LLC·1 device

Specimen Receptacles

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EU IVDR · Eu Ivd Class A ·Advanced Instruments, LLC·6 devices

Factor XIII

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EU IVDR · Eu Ivd Class B ·KAMIYA BIOMEDICAL COMPANY, LLC·3 devices

Gold Standard Diagnostics Rapid Plasma Reagin (RPR) Test System-5C

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EU IVDD · Eu Ivd General ·Gold Standard Diagnostics, LLC·1 device

HAILSTORM

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EU IVDR · Eu Ivd Class A ·Gold Standard Diagnostics, LLC·1 device

Gold Standard Diagnostics Rapid Plasma Reagin (RPR) Test System

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EU IVDD · Eu Ivd General ·Gold Standard Diagnostics, LLC·1 device

AIX1000 Analyzer

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EU IVDD · Eu Ivd General ·Gold Standard Diagnostics, LLC·1 device

Bolt

Basic UDI-DI
EU IVDR · Eu Ivd Class A ·Gold Standard Diagnostics, LLC·1 device