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In vitro diagnostic medical devices
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Immunochemistry (immunology)
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Immunochemistry - rapid tests & point of care
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Tumour markers rt & poc
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Psa - rt & poc
Psa - rt & poc
W0102160202
31 devices
Devices
One Step Prostate Specific Antigen (PSA) Whole Blood/Serum/Plasma Test
Guangzhou Wondfo Biotech Co., Ltd.
·
,
CN
IVD Annex II List B
CE/IVDD
Newfoundland
PRIMA Lab SA
·
,
CH
IVD Annex II List B
CE/IVDD
Simple PSA / Stick PSA
Operon, S.A.
·
,
ES
IVD Annex II List B
CE/IVDD
Fortel® Prostate (PSA) Screening Test
Biomerica, Inc.
·
,
US
IVD Annex II List B
CE/IVDD
SOFTEC Creatine Kinase-MB Rapid Test Kit
Zet Medi̇kal Teksti̇l Diş Ti̇c. Ltd. Şti̇.
·
,
TR
IVD General
CE/IVDD
Total Prostate Specific Antigen (t-PSA) Detection Kit（Fluorescence immunochroma…
Biobase Poct Co., Ltd
·
,
CN
IVD General
CE/IVDD
One Step Prostate Specific Antigen (PSA) Serum/Plasma Test
Guangzhou Wondfo Biotech Co., Ltd.
·
,
CN
IVD Annex II List B
CE/IVDD
PSA Assay Kit (Fluorescence Immunoassay)
DiYaLab ZJG Biotech Co., Ltd
·
,
CN
IVD General
CE/IVDD
Prostate- Specific Antigen (PSA) Rapid Test
Hangzhou Alltest Biotech.Co., Ltd.
·
,
CN
Class C
CE/IVDR
EU-TDA-FI-51326-800081-2026
Active
Valid to Apr 2031
Finecare™ FPSA (Free Prostate Specific Antigen) Rapid Quantitative Test
Guangzhou Wondfo Biotech Co., Ltd.
·
,
CN
IVD Annex II List B
CE/IVDD
Prostate- Specific Antigen (PSA) Rapid Test
Hangzhou Alltest Biotech.Co., Ltd.
·
,
CN
Class C
CE/IVDR
EU-TDA-FI-51326-800081-2026
Active
Valid to Apr 2031
Prostate Specific Antigen (PSA) Rapid Test Strip (Whole blood +2 more)
Zhejiang Orient Gene Biotech Co., Ltd.
·
,
CN
IVD Annex II List B
CE/IVDD
Finecare
Guangzhou Wondfo Biotech Co., Ltd.
·
,
CN
IVD Annex II List B
CE/IVDD
One Step Prostate Specific Antigen (PSA) Serum/Plasma Test
Guangzhou Wondfo Biotech Co., Ltd.
·
,
CN
IVD Annex II List B
CE/IVDD
NADAL® PSA Test (CE0197)
nal von minden GmbH
·
,
DE
IVD Annex II List B
CE/IVDD
TruVue
BioFynder Limited
·
,
GB
IVD General
CE/MDR
PSA Detection Kit (Immunofluorescence Chromatography)
Dezhou Guoke Medical Technology Co., Ltd.
·
,
CN
IVD General
CE/IVDD
Prostate Specific Antigen Rapid Test
Shanghai Chemtron Biotech Co., Ltd.
·
,
CN
IVD Annex II List B
CE/IVDD
Prostate- Specific Antigen (PSA) Rapid Test
Hangzhou Alltest Biotech.Co., Ltd.
·
,
CN
Class C
CE/IVDR
EU-TDA-FI-51326-800081-2026
Active
Valid to Apr 2031
Fortel Prostate (PSA) Screening Test
BIOEUROPE GmbH
·
,
DE
IVD Annex II List B
CE/IVDD
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