Nantong MedTech Medical Products Co., Ltd.

Manufacturer

🇨🇳 China·1 Importer

Devon Medical Technology (Jiangsu) Ltd.

Manufacturer

🇨🇳 China

Hangzhou Immuno Biotech Co., Ltd

Manufacturer

🇨🇳 China·72 Basic UDI-DIs·72 Devices

Zhuhai Keyu Biological Engineering Co., Ltd

Manufacturer

🇨🇳 China·47 Basic UDI-DIs·47 Devices

Test, Prostate Specific Antigen, Free, (Noncomplexed) To Distinguish Prostate Cancer From Benign Conditions

FDA Pre-Market Approval

FDA Class 3 ·ABBOTT IMX FREE PSA

W.H.P.M. Bioresearch & Technology Co., Ltd.

Manufacturer

🇨🇳 China·27 Basic UDI-DIs·27 Devices·7 Importers·TÜV Rheinland LGA Products GmbH

Test, Prostate Specific Antigen, Free, (Noncomplexed) To Distinguish Prostate Cancer From Benign Conditions

FDA Pre-Market Approval

FDA Class 3 ·ABBOTT ARCHITECT FREE PSA

Assure Tech. (Hangzhou) Co., Ltd.

Manufacturer

🇨🇳 China·212 Basic UDI-DIs·212 Devices·2 Importers·TÜV Rheinland LGA Products GmbH, CeCert Sp. z o.o., TÜV Rheinland LGA Products GmbH, 3EC International a.s., TÜV Rheinland LGA Products GmbH, TÜV Rheinland LGA Products GmbH, CeCert Sp. z o.o., POLSKIE CENTRUM BADAN I CERTYFIKACJI S.A., and TÜV Rheinland LGA Products GmbH

Test, Prostate Specific Antigen, Free, (Noncomplexed) To Distinguish Prostate Cancer From Benign Conditions

FDA Pre-Market Approval

FDA Class 3 ·VIDAS FREE PSA RT ASSAY

Zybio Inc.

Manufacturer

🇨🇳 China·147 Basic UDI-DIs·212 Devices·3 Importers

Test, Prostate Specific Antigen, Free, (Noncomplexed) To Distinguish Prostate Cancer From Benign Conditions

FDA Pre-Market Approval

FDA Class 3 ·ABBOTT AXSYM FREE PSA ASSAY

Test, Prostate Specific Antigen, Free, (Noncomplexed) To Distinguish Prostate Cancer From Benign Conditions

FDA Pre-Market Approval

FDA Class 3 ·IMMULITE / IMMULITE 1000 AND IMMULITE 2000 FREE PSA ASSAYS

Hangzhou Alltest Biotech.Co.,Ltd.

Manufacturer

🇨🇳 China·119 Basic UDI-DIs·171 Devices·32 Importers·TÜV SÜD Product Service GmbH, TÜV SÜD Product Service GmbH, POLSKIE CENTRUM BADAN I CERTYFIKACJI S.A., CeCert Sp. z o.o., POLSKIE CENTRUM BADAN I CERTYFIKACJI S.A., CeCert Sp. z o.o., TÜV SÜD Product Service GmbH, TÜV SÜD Product Service GmbH, TÜV SÜD Product Service GmbH, and TÜV SÜD Product Service GmbH

WenZhou Emma Optics Co.,Ltd.

Manufacturer

🇨🇳 China

Analyzer, Chemistry (Photometric, Discrete), For Clinical Use

FDA Pre-Market Approval

FDA Class 1 ·ABBOTT AXSYM TOTAL PSA ASSAY

BXTAccelyon NL B.V.

Importer

🇳🇱 Netherlands

simovision bv NL

Importer

🇳🇱 Netherlands

LG Electronics France

Importer

🇫🇷 France

LG Electronics Latvia

Importer

🇱🇻 Latvia

P2psa

FDA Pre-Market Approval

FDA Class 3 ·ACCESS HYBRITECH P2PSA ON THE ACCESS IMMUNOASSAY SYSTEMS