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

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Ultra-Low PSA Control (UL PSA Control)

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EU IVDR · Eu Ivd Class C ·Randox Laboratories Limited·1 device

PSA-RIACT

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EU IVDD · Eu Ivd Annex 2 List B ·Cisbio Bioassays·1 device

f-PSA (CLIA)

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

iFlash-Total PSA

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EU IVDD · Eu Ivd Annex 2 List B ·SHENZHEN YHLO BIOTECH CO., LTD.·1 device

PSA Rapid Test

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EU IVDD · Eu Ivd Annex 2 List B ·Shenzhen Kang Sheng Bao Bio-Technology Co.,Ltd.·1 device

iFlash-Free PSA

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EU IVDD · Eu Ivd Annex 2 List B ·SHENZHEN YHLO BIOTECH CO., LTD.·1 device

HOKAPI™ PSA

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EU IVDD · Eu Ivd Annex 2 List B ·Suzhou Hokapi Biomedical Engineering Co., Ltd..·1 device

PSA Rapid Test

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EU IVDD · Eu Ivd Annex 2 List B ·Shenzhen Kang Sheng Bao Bio-Technology Co.,Ltd.·1 device

Total Prostate Specific Antigen(CLIA)、Total PSA Calibrators

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

Access Hybritech PSA (QC)

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EU IVDR · Eu Ivd Class C ·Beckman Coulter Inc.·1 device

Access Hybritech PSA (Calibrator)

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EU IVDR · Eu Ivd Class C ·Beckman Coulter Inc.·1 device

PSA total IRMA KIT

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EU IVDR · Eu Ivd Class C ·IMMUNOTECH s.r.o.·1 device

PSA free IRMA KIT

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EU IVDR · Eu Ivd Class C ·IMMUNOTECH s.r.o.·1 device

Access Hybritech PSA Calibrators

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

Access Hybritech PSA QC

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

Access Hybritech free PSA (QC)

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EU IVDR · Eu Ivd Class C ·Beckman Coulter Inc.·1 device

Access Hybritech free PSA (Calibrators)

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EU IVDR · Eu Ivd Class C ·Beckman Coulter Inc.·1 device

Access Hybritech PSA (Sample Diluent)

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EU IVDR · Eu Ivd Class C ·Beckman Coulter Inc.·1 device

Access Hybritech PSA (Reagent Pack)

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EU IVDR · Eu Ivd Class C ·Beckman Coulter Inc.·2 devices

Access Hybritech PSA Sample Diluent

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