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In vitro diagnostic medical devices
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Immunochemistry (immunology)
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Tumour markers
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Cancer antigens
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Total prostatic specific antigen
Total prostatic specific antigen
W0102030113
72 devices
tPSA CLIA Microparticles
Autobio Diagnostics Co., Ltd.
·
,
China
Class C
CE/IVDR
Access Hybritech PSA (Sample Diluent)
Beckman Coulter, Inc.
·
,
United States
Class C
CE/IVDR
GUDID
on market
Total Prostate Specific Antigen (eCLIA)
Shenzhen Lifotronic Technology Co., Ltd.
·
,
China
Class C
CE/IVDR
Prostate Specific Antigen（PSA）Rapid Quantitative Test（Fluorescence immunoassay）
WWHS Biotech.Inc
·
,
China
IVD General
CE/IVDD
tPSA CLIA Microparticles
Autobio Diagnostics Co., Ltd.
·
,
China
Class C
CE/IVDR
Total Prostate Specific Antigen (tPSA) Assay Kit (Chemiluminescent Immunoassay)
Wuhan Life Origin Biotech Joint Stock Co., Ltd.
·
,
China
IVD General
CE/IVDD
Chemiluminescent Immunoassay Assay Kits for Free Prostate Specific Antigen (t-P…
Maccura Biotechnology Co., Ltd.
·
,
China
IVD Annex II List B
CE/IVDD
Innodx T-Psa Cmia
Xiamen Innodx Biotech Co., Ltd.
·
,
China
Class C
CE/IVDR
Innodx T-Psa Cmia
Xiamen Innodx Biotech Co., Ltd.
·
,
China
Class C
CE/IVDR
Total Prostate Specific Antigen (tPSA) Assay Kit (Chemiluminescent Immunoassay)
Wuhan Life Origin Biotech Joint Stock Co., Ltd.
·
,
China
IVD General
CE/IVDD
Total Prostate Specific Antigen (eCLIA)
Shenzhen Lifotronic Technology Co., Ltd.
·
,
China
Class C
CE/IVDR
Hokapi™ Psa
Suzhou Hokapi Biomedical Engineering Co., Ltd..
·
,
China
Class C
CE/IVDR
Innodx T-Psa Cmia
Xiamen Innodx Biotech Co., Ltd.
·
,
China
Class C
CE/IVDR
Total Prostate-Specific Antigen Assay Kit (Immunochromatographic Assay)
Wuhan Life Origin Biotech Joint Stock Co., Ltd.
·
,
China
IVD General
CE/IVDD
Access Hybritech PSA (Reagent Pack)
Beckman Coulter, Inc.
·
,
United States
Class C
CE/IVDR
GUDID
on market
FREND PSA Plus
NanoEnTek, Inc.
·
,
South Korea
IVD Annex II List B
FDA 510(k)
K162378
Active
Cleared 17 May 2017
CE/IVDD
+1
authorizations
Innodx T-Psa Cmia
Xiamen Innodx Biotech Co., Ltd.
·
,
China
Class C
CE/IVDR
CancerCheck® PSA
Shenzhen Kang Sheng Bao Bio-Technology Co., Ltd.
·
,
China
IVD Annex II List B
CE/IVDD
Cancer Antigen 72-4 (CA72-4) Determination Kit (Chemiluminescence Immunoassay)
Shenzhen Channel Biotechnology Co., Ltd.
·
,
China
IVD General
CE/IVDD
Total Prostate Specific Antigen test (Chemiluminescence Immunoassay)
Beijing Hotgen Biotech Co., Ltd.
·
,
China
Class C
CE/IVDR
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