Antigen(Complexed),Prostate Specific,(Cpsa)

FDA Pre-Market Approval

FDA Class 3 ·ADVIA Centaur® and Atellica® IM AFP, ADVIA Centaur® and Atellica® IM PSA, ADVIA Centaur® and Atellica® IM cPSA

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

FDA Pre-Market Approval

FDA Class 3 ·ADVIA Centaur® and Atellica® IM AFP, ADVIA Centaur® and Atellica® IM PSA, ADVIA Centaur® and Atellica® IM cPSA

Kit, Test, Alpha-Fetoprotein For Neural Tube Defects

FDA Pre-Market Approval

FDA Class 3 ·ADVIA Centaur® and Atellica® IM AFP, ADVIA Centaur® and Atellica® IM PSA, ADVIA Centaur® and Atellica® IM cPSA

ENERPEEL SA

Basic UDI-DI

EU MDD · Eu Md Class 2a ·GENERAL TOPICS SRL·1 device

ENERPEEL SA-15

Basic UDI-DI

EU MDD · Eu Md Class 2a ·GENERAL TOPICS SRL·1 device

qct-0120-19

Certificate

MDD Annex II (excluding section 4)·G P S S.R.L. ·ISTITUTO SUPERIORE DI SANITA'·1 Basic UDI-DI

QCT-0120-19

Certificate

MDD Annex II (excluding section 4)·G P S S.R.L. ·ISTITUTO SUPERIORE DI SANITA'·3 Basic UDI-DIs

IMMCO DIAGNOSTICS

FDA UDI

IMMCO DIAGNOSTICS, INC.·00845714004247·WASH BUFFER

1 Minute Pour mes Reins

Basic UDI-DI

EU MDD · Eu Md Class 1 ·NEWCARD·1 device

1 Minute Pour mon Cœur

Basic UDI-DI

EU MDD · Eu Md Class 1 ·NEWCARD·1 device

Prostate-Specific Antigen (Psa) For Prognostic, Recurrence Risk Assessment Of Prostate Cancers

FDA classification

FDA Class 2 ·Prostate-Specific Antigen (Psa) For Prognostic, Recurrence Risk Assessment Of Prostate Cancers

Compagnia Italiana Oftalmologica scarl

Importer

🇮🇹 Italy·8 Manufacturers

France Chirurgie Instrumentation SAS

Importer

🇫🇷 France·13 Manufacturers

W2O Medizintechnik AG

Importer

🇩🇪 Germany·14 Manufacturers

AF Pharma Service Europe SL

Authorized representative

🇪🇸 Spain·51 Manufacturers·881 Devices

Kuomed Oy

Importer

🇫🇮 Finland·21 Manufacturers

ADVIA Centaur

FDA registration

Siemens Healthcare Diagnostics Inc.·41 products·🇺🇸 United States

ADVIA Centaur

FDA registration

Siemens Healthcare Diagnostics Inc.·41 products·🇺🇸 United States

ADVIA Centaur

FDA registration

Siemens Healthcare Diagnostics Manufacturing Ltd.·41 products·🇮🇪 Ireland

Dimension(r) Reaction Vessels

FDA registration

Carclo Technical Plastics - Latrobe·58 products·🇺🇸 United States