Protective Barrier Enclosure

FDA classification

FDA Not Classified ·Protective Barrier Enclosure

Des-Gamma-Carboxy-Prothrombin (Dcp), Risk Assessment, Hepatocellular Carcinoma

FDA classification

FDA Class 2 ·Des-Gamma-Carboxy-Prothrombin (Dcp), Risk Assessment, Hepatocellular Carcinoma

medac GmbH

Importer

🇩🇪 Germany·7 Manufacturers

Remote Or Wearable Patient Monitoring Device For Drug Induced Qt Prolongation Monitoring

FDA classification

FDA Not Classified ·Remote Or Wearable Patient Monitoring Device For Drug Induced Qt Prolongation Monitoring

Over-The-Counter Molecular Test To Detect Sars-Cov-2 From Clinical Specimens

FDA classification

FDA Class 2 ·Over-The-Counter Molecular Test To Detect Sars-Cov-2 From Clinical Specimens

Hab Gov Strategics Applied Technologies Limited

Authorized representative

🇲🇹 Malta·2 Manufacturers·5 Devices

Eurobio Scientific

Importer

🇫🇷 France·8 Manufacturers

EUROMEDISHOP

FDA registration

EUROMEDISHOP·13 products·🇫🇷 France

Clinitek Status+

FDA registration

SIEMENS HEALTHCARE DIAGNOSTICS MANUFACTURING LTD·13 products·🇬🇧 United Kingdom

Clinitek Status+

FDA registration

Siemens Healthcare Diagnostics Inc·13 products·🇺🇸 United States

Clinitek Status+

FDA registration

Siemens Healthcare Diagnostics Inc.·13 products·🇺🇸 United States

Clinitek Status Connector

FDA UDI

Siemens Healthcare Diagnostics Inc.·00630414607962·The CLINITEK Status Connector is intended for u...

CLINITEK Status® Connector

FDA UDI

Siemens Healthcare Diagnostics Inc.·00630414571263·The CLINITEK Status® Connector is intended for ...

CLINITEK Status®+ Analyzer

FDA UDI

Siemens Healthcare Diagnostics Inc.·00630414572314·The CLINITEK Status+ Urine Chemistry Analyzer i...

CLINITEK Status® Connector

FDA UDI

Siemens Healthcare Diagnostics Inc.·00630414578330·The CLINITEK Status® Connector is intended for ...

CLINITEK Status®+ Analyzer

FDA UDI

Siemens Healthcare Diagnostics Inc.·00630414574639·The CLINITEK Status+ Urine Chemistry Analyzer i...

SYNCHRON UniCel DxC 600i, 800i, 660i, 860i

FDA registration

BECKMAN COULTER, INC.·18 products·🇺🇸 United States

Serology Test Used For Screening Of Cadaveric (Non-Heart-Beating) Donors Of Blood Or Blood Products Or Hct/Ps

FDA classification

FDA Unclassified ·Serology Test Used For Screening Of Cadaveric (Non-Heart-Beating) Donors Of Blood Or Blood Products Or Hct/Ps

Nucleic Acid Test Used For Screening Of Cadaveric (Non-Heart-Beating) Donors Of Blood Or Blood Products Or Hct/Ps

FDA classification

FDA Unclassified ·Nucleic Acid Test Used For Screening Of Cadaveric (Non-Heart-Beating) Donors Of Blood Or Blood Products Or Hct/Ps

Test, Hepatitis B (B Core, Be Antigen, Be Antibody, B Core Igm)

FDA Pre-Market Approval

FDA Class 3 ·VITROS IMMUNODIAGNOSTIC PRODUCT HBSAG REAGENT PACK & CALIBRATOR & VITROS IMMUNODIAGNOSTIC PRODUCTS HBSAG CONFIRMATORY KI