Planmeca Oy

Importer

🇫🇮 Finland·8 Manufacturers

France Chirurgie Instrumentation SAS (FCI S.A.S.)

System producer

🇫🇷 France

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

FDA Pre-Market Approval

FDA Class 3 ·VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HBS QUANTITATIVE REAGENT PACK, VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HBS CALIBRATS

Human Care HC AB

Authorized representative

🇸🇪 Sweden

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...

Global Regulatory Solutions HC B.V.

Authorized representative

🇳🇱 Netherlands·1 Manufacturer·1 Device

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

Human Lyophilized Dura Mater

FDA classification

FDA Class 2 ·Human Lyophilized Dura Mater

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

ADVIA Centaur Intact Parathyroid Hormone (iPTH)

FDA registration

Siemens Healthcare Diagnostics Inc.·29 products·🇺🇸 United States

Analyzer

FDA registration

Diamond Diagnostics Inc.·29 products·🇭🇺 Hungary