241 results · 16ms · Sources: EU EUDAMED, US FDA

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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 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

NeoMass AAAC Plus DBS controls

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EU IVDD · Eu Ivd Annex 2 List B ·Labsystems Diagnostics Oy·1 device

DELFIA/AutoDELFIA PAPP-A/Free hCGβ Dual DBS kit 

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EU IVDD · Eu Ivd Annex 2 List B ·Wallac Oy·1 device

Creatine kinase MB(CLIA)、CK-MB Calibrators

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

PRG CLIA Microparticles

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EU IVDR · Eu Ivd Class B ·Autobio Diagnostics Co., Ltd.·1 device

AutoLumo analyzer

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EU IVDR · Eu Ivd Class C ·Autobio Diagnostics Co., Ltd.·2 devices

AutoLumo analyzer

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EU IVDR · Eu Ivd Class C ·Autobio Diagnostics Co., Ltd.·2 devices

AutoLumo analyzer

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EU IVDR · Eu Ivd Class B ·Autobio Diagnostics Co., Ltd.·2 devices

AutoLumo analyzer

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EU IVDR · Eu Ivd Class C ·Autobio Diagnostics Co., Ltd.·3 devices

AutoLumo analyzer

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EU IVDR · Eu Ivd Class C ·Autobio Diagnostics Co., Ltd.·3 devices

AutoLumo analyzer

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EU IVDR · Eu Ivd Class C ·Autobio Diagnostics Co., Ltd.·3 devices

FSH CLIA Microparticles

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EU IVDR · Eu Ivd Class B ·Autobio Diagnostics Co., Ltd.·1 device

Testosterone CLIA Microparticles

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EU IVDR · Eu Ivd Class B ·Autobio Diagnostics Co., Ltd.·1 device

PRL CLIA Microparticles

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EU IVDR · Eu Ivd Class B ·Autobio Diagnostics Co., Ltd.·1 device

LH CLIA Microparticles

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EU IVDR · Eu Ivd Class B ·Autobio Diagnostics Co., Ltd.·1 device