32 results · 7ms · Sources: EU EUDAMED, US FDA

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Sentosa SQ HIV Genotyping Assay (4x16)

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EU IVDD · Eu Ivd Annex 2 List A ·Vela Operations Singapore Pte. Ltd.·1 device

Sentosa SQ HCV Genotyping Assay (4x16)

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EU IVDD · Eu Ivd Annex 2 List A ·Vela Operations Singapore Pte. Ltd.·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)

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

PoET Master Positive Control

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EU IVDD · Eu Ivd Annex 2 List A ·Gesellschaft zur Forschung, Entwicklung und Distribution von Diagnostika im Blutspendewesen mbH·1 device

Nucleic Acid Test Kit for HBV, HCV, HIV (Type1+2) (Real-time PCR)

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EU IVDD · Eu Ivd Annex 2 List A ·Sanway Gene Tech. Inc.·1 device

HBV RealQuant™ PCR

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EU IVDD · Eu Ivd Annex 2 List A ·General Biologicals Corporation·1 device

abia HIV AgAb

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EU IVDD · Eu Ivd Annex 2 List A ·AB Diagnostic Systems GmbH·1 device

abia HIV AgAb

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EU IVDD · Eu Ivd Annex 2 List A ·AB Diagnostic Systems GmbH·1 device

HIV 1/2/O Tri-line Human Immunodeficiency Virus Rapid Test Device (Whole Blood/Serum/Plasma)

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EU IVDD · Eu Ivd Annex 2 List A ·Abon Biopharm(Hangzhou) Co., Ltd·1 device

HCV Hepatitis C Virus Rapid Test Device (Serum/Plasma)

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EU IVDD · Eu Ivd Annex 2 List A ·Abon Biopharm(Hangzhou) Co., Ltd·1 device

MP Diagnostics HBsAg ELISA 4.1

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EU IVDD · Eu Ivd Annex 2 List A ·MP Biomedicals Asia Pacific Pte Ltd·1 device

HBsAg Hepatitis B Surface Antigen Rapid Test Device (Whole Blood/Serum/Plasma)

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EU IVDD · Eu Ivd Annex 2 List A ·Abon Biopharm(Hangzhou) Co., Ltd·1 device

MP Diagnostics HBsAg ELISA 4.1

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EU IVDD · Eu Ivd Annex 2 List A ·MP Biomedicals Asia Pacific Pte Ltd·1 device

MP Diagnostics HCV ELISA 4.0

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EU IVDD · Eu Ivd Annex 2 List A ·MP Biomedicals Asia Pacific Pte Ltd·1 device

MP Diagnostics HCV ELISA 4.0

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EU IVDD · Eu Ivd Annex 2 List A ·MP Biomedicals Asia Pacific Pte Ltd·1 device

MP Diagnostics HIV Ag/Ab Combo ELISA 4.0

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EU IVDD · Eu Ivd Annex 2 List A ·MP Biomedicals Asia Pacific Pte Ltd·1 device

MP Diagnostics HIV Ag/Ab Combo ELISA 4.0

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EU IVDD · Eu Ivd Annex 2 List A ·MP Biomedicals Asia Pacific Pte Ltd·1 device

Access anti-HCV

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EU IVDD · Eu Ivd Annex 2 List A ·Beckman Coulter Inc.·1 device