CLOST. DIFF. INCL GDH AND/OR TOXIN A AND B - RT & POC

Device

EU IVDD · Eu Ivd General ·Ameritech Diagnostic Reagent (Jiaxing) Co., Ltd.·On the market·13 countries

System, Nucleic Acid Amplification Test, Dna, Antimicrobial Resistance Marker, Direct Specimen

FDA classification

FDA Class 2 ·System, Nucleic Acid Amplification Test, Dna, Antimicrobial Resistance Marker, Direct Specimen

ROTEM®

FDA UDI

Tem Innovations GmbH·04260160470327·The ROTEM sigma is an in vitro diagnostic (IVD)...

ROTEM®

FDA UDI

Tem Innovations GmbH·04260160470358·The ROTEM sigma is an in vitro diagnostic (IVD)...

ROTEM®

FDA UDI

Tem Innovations GmbH·04260160470341·The ROTEM sigma is an in vitro diagnostic (IVD)...

ROTEM®

FDA UDI

Tem Innovations GmbH·04260160470372·The ROTEM sigma is an in vitro diagnostic (IVD)...

SPIFE Urine IFE Accessories

FDA registration

HELENA LABORATORIES, CORP.·1 product·🇺🇸 United States

SPIFE Urine IFE Accessories

FDA registration

HELENA LABORATORIES, CORP.·1 product·🇺🇸 United States

Epocal Inc.

Manufacturer

🇨🇦 Canada·2 Importers·TÜV Rheinland LGA Products GmbH

Epocal Inc.

Manufacturer

🇨🇦 Canada·2 Importers

Doc-Invent SA

Manufacturer

🇨🇭 Switzerland·1 Basic UDI-DI·1 Device

Doc Cirrus GmbH

Manufacturer

🇩🇪 Germany

DOC medikus GmbH

Manufacturer

🇦🇹 Austria

MR DOC S.R.L.

Manufacturer

🇮🇹 Italy·1 Basic UDI-DI·1 Device·TUV Rheinland Italia SRL

PHC Corporation In Vitro Diagnostics Division

Manufacturer

🇯🇵 Japan·1 Basic UDI-DI·5 Devices·1 Importer

PHC Corporation

Manufacturer

🇯🇵 Japan·4 Basic UDI-DIs·6 Devices·1 Importer

Visibly, Inc.

Manufacturer

🇺🇸 United States

PHC Corporation

Manufacturer

🇯🇵 Japan·1 Basic UDI-DI·1 Device

GW Pharmaceuticals Limited

Manufacturer

Personalized PseudoPatient™ PV

FDA registration

RTSAFE, P.C.·1 product·🇬🇷 Greece