1,852 results · 22ms · Sources: EU EUDAMED, US FDA

Human Epididymis Protein 4 test (Chemiluminescence Immunoassay)

Basic UDI-DI
EU IVDR · Eu Ivd Class C ·Beijing Hotgen Biotech Co., Ltd.·1 device

Procalcitonin test (chemiluminescence immunoassay)

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EU IVDR · Eu Ivd Class C ·Beijing Hotgen Biotech Co., Ltd.·1 device

High sensitive Cardiac Troponin-I test (Chemiluminescence Immunoassay)

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EU IVDR · Eu Ivd Class C ·Beijing Hotgen Biotech Co., Ltd.·1 device

Total Prostate Specific Antigen (PSA) (Light-initiated Chemiluminescence Immunoassay, LiCA)

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EU IVDR · Eu Ivd Class C ·Chemclin Diagnostics Co., Ltd.·4 devices

MH Guide

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EU IVDR · Eu Ivd Class C ·Molecular Health GmbH·7 devices

Amino Acids and Acylcarnitines in Dried Blood Spots (DBS)

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EU IVDR · Eu Ivd Class C ·RECIPE Chemicals + Instruments GmbH·4 devices

Immunosuppressants in Whole Blood

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EU IVDR · Eu Ivd Class C ·RECIPE Chemicals + Instruments GmbH·4 devices

Antiepileptics in Serum / Plasma

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EU IVDR · Eu Ivd Class C ·RECIPE Chemicals + Instruments GmbH·2 devices

DNA Methylation Detection Kit for Human SDC2, ADHFE1 and PPP2R5C Genes (Real-Time PCR)

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EU IVDR · Eu Ivd Class C ·ENVELOPE HEALTH BIOTECHNOLOGY CO., LTD.·2 devices

Newbio TPHA 100

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EU IVDR · Eu Ivd Class C ·Newmarket Biomedical Ltd·6 devices

Newbio RPR 100

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EU IVDR · Eu Ivd Class C ·Newmarket Biomedical Ltd·4 devices

Human Papillomavirus (HPV) Nucleic Acid Detection Kit (Hybrid Capture-CLIA)

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EU IVDR · Eu Ivd Class C ·Hangzhou Dalton BioSciences, Ltd.·4 devices

AMPLIRUN® HERPES SIMPLEX 2 DNA CONTROL

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EU IVDR · Eu Ivd Class C ·Vircell, S.L·1 device

Full Range C-Reactive Protein Test Kit (Latex-Enhanced Immunoturbidimetric Assay)

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EU IVDR · Eu Ivd Class C ·URIT Medical Electronic Co.,Ltd.·5 devices

Lactate Dehydrogenase Reagent Kit (Lactic Acid Substrate Method)

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EU IVDR · Eu Ivd Class C ·URIT Medical Electronic Co.,Ltd.·4 devices

AMPLIRUN® VARICELLA-ZOSTER VIRUS DNA CONTROL

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EU IVDR · Eu Ivd Class C ·Vircell, S.L·1 device

MBC125

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EU IVDR · Eu Ivd Class C ·Vircell, S.L·1 device

Hemoglobin A1c Analytical Column

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

AMPLIRUN® NEISSERIA GONORRHOEAE DNA CONTROL

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EU IVDR · Eu Ivd Class C ·Vircell, S.L·1 device

MBC019

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EU IVDR · Eu Ivd Class C ·Vircell, S.L·1 device