459 results · 15ms · Sources: EU EUDAMED, US FDA

EZ-PSA Professional PSA Test

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

Ultra-Low PSA Control (UL PSA Control)

Basic UDI-DI
EU IVDR · Eu Ivd Class C ·Randox Laboratories Limited·1 device

PSA-RIACT

Basic UDI-DI
EU IVDD · Eu Ivd Annex 2 List B ·Cisbio Bioassays·1 device

f-PSA (CLIA)

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

iFlash-Total PSA

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

PSA Rapid Test

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

iFlash-Free PSA

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

HOKAPI™ PSA

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

PSA Rapid Test

Basic UDI-DI
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

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

Access Hybritech PSA (QC)

Basic UDI-DI
EU IVDR · Eu Ivd Class C ·Beckman Coulter Inc.·1 device

Access Hybritech PSA (Calibrator)

Basic UDI-DI
EU IVDR · Eu Ivd Class C ·Beckman Coulter Inc.·1 device

PSA total IRMA KIT

Basic UDI-DI
EU IVDR · Eu Ivd Class C ·IMMUNOTECH s.r.o.·1 device

PSA free IRMA KIT

Basic UDI-DI
EU IVDR · Eu Ivd Class C ·IMMUNOTECH s.r.o.·1 device

Access Hybritech PSA Calibrators

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

Access Hybritech PSA QC

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

Prostate Specific Antigen (PSA) Test

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

Access Hybritech free PSA (QC)

Basic UDI-DI
EU IVDR · Eu Ivd Class C ·Beckman Coulter Inc.·1 device

Access Hybritech free PSA (Calibrators)

Basic UDI-DI
EU IVDR · Eu Ivd Class C ·Beckman Coulter Inc.·1 device

Access Hybritech PSA (Sample Diluent)

Basic UDI-DI
EU IVDR · Eu Ivd Class C ·Beckman Coulter Inc.·1 device