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

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f-PSA (CLIA)

Basic UDI-DI
EU IVDD · Eu Ivd Annex 2 List B ·Shenzhen New Industries Biomedical Engineering Co., Ltd.·1 device

MycoMDx Carbapenem resistance gene Assay (F-PCR)

Basic UDI-DI
EU IVDD · Eu Ivd General ·Dynamiker Biotechnology (Tianjin) Co., Ltd.·1 device

MycoMDx Carbapenem resistance gene Assay (F-PCR)

Basic UDI-DI
EU IVDD · Eu Ivd General ·Dynamiker Biotechnology (Tianjin) Co., Ltd.·1 device

Adenovirus Group F Nucleic Acid Diagnostic Kit (PCR-Fluorescence Probing)

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EU IVDD · Eu Ivd General ·Sansure Biotech Inc.·1 device

Adenovirus Group F Nucleic Acid Diagnostic Kit (PCR-Fluorescence Probing)

Basic UDI-DI
EU IVDD · Eu Ivd General ·Sansure Biotech Inc.·1 device

MycoMDx Mycobacterium tuberculosis complex nucleic acid test kit (F-PCR)

Basic UDI-DI
EU IVDD · Eu Ivd General ·Dynamiker Biotechnology (Tianjin) Co., Ltd.·1 device

MycoMDx Mycobacterium tuberculosis complex nucleic acid test kit (F-PCR)

Basic UDI-DI
EU IVDD · Eu Ivd General ·Dynamiker Biotechnology (Tianjin) Co., Ltd.·1 device

Chemiluminescent Immunoassay Assay Kits for Total Prostate Specific Antigen (f-PSA)

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EU IVDD · Eu Ivd Annex 2 List B ·Maccura Biotechnology Co., Ltd. ·1 device

Chemiluminescent Immunoassay Assay Kits for Total Prostate Specific Antigen (f-PSA)

Basic UDI-DI
EU IVDD · Eu Ivd Annex 2 List B ·Maccura Biotechnology Co., Ltd. ·1 device

Chemiluminescent Immunoassay Assay Kits for Total Prostate Specific Antigen (f-PSA)

Basic UDI-DI
EU IVDD · Eu Ivd Annex 2 List B ·Maccura Biotechnology Co., Ltd. ·1 device

Human Cytomegalovirus DNA Quantitative Fluorescence Diagnostic Kit (PCR-Fluorescence Probing)

Basic UDI-DI
EU IVDD · Eu Ivd Annex 2 List B ·Sansure Biotech Inc.·1 device

Chlamydia Trachomatis/Ureaplasma Urealyticum/Neisseria Gonorrhoeae DNA Diagnostic Kit (PCR-Fluorescence Probing)

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EU IVDD · Eu Ivd Annex 2 List B ·Sansure Biotech Inc.·1 device

Chlamydia Trachomatis DNA Fluorescence Diagnostic Kit (PCR-Fluorescence Probing)

Basic UDI-DI
EU IVDD · Eu Ivd Annex 2 List B ·Sansure Biotech Inc.·1 device

Hepatitis B Virus DNA Quantitative Fluorescence Diagnostic Kit (PCR-Fluorescence Probing)

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EU IVDD · Eu Ivd Annex 2 List A ·Sansure Biotech Inc.·1 device

Hepatitis C Virus RNA Quantitative Fluorescence Diagnostic Kit (PCR-Fluorescence Probing)

Basic UDI-DI
EU IVDD · Eu Ivd Annex 2 List A ·Sansure Biotech Inc.·1 device

Allergen Discs Asp o 2 Alpha-Amylase (Asp.oryzae)

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EU IVDD · Eu Ivd General ·Gold Standard Diagnostics Kassel GmbH·1 device

Allergen Discs r-Alt a 1 (Alternaria ten)

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EU IVDD · Eu Ivd General ·Gold Standard Diagnostics Kassel GmbH·1 device

Human Immunodeficiency Virus Type 1 RNA Quantitative Fluorescence Diagnostic Kit (PCR-Fluorescence Probing)

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EU IVDD · Eu Ivd Annex 2 List A ·Sansure Biotech Inc.·1 device

abia HIV AgAb

Basic UDI-DI
EU IVDD · Eu Ivd Annex 2 List A ·AB Diagnostic Systems GmbH·1 device

abia HIV AgAb

Basic UDI-DI
EU IVDD · Eu Ivd Annex 2 List A ·AB Diagnostic Systems GmbH·1 device