476846 Gamma-Glutamyl Transferase Reagent (?-GT 2 x 400)

FDA registration

BECKMAN COULTER, INC.·5 products·🇺🇸 United States

Acuitas

FDA UDI

Opgen, Inc.·01812125010067·QuantStudio Real-Time PCR Instrument Qualified ...

Gram-Positive Blood Culture (BC-GP) Nucleic Acid Test Cartridge

FDA UDI

NANOSPHERE, INC.·00857573006119·The Verigene® Gram-Positive Blood Culture Nuc...

Acuitas

FDA UDI

Opgen, Inc.·20812125010062·QuantStudio Real-Time PCR Instrument Qualified ...

Gram-Positive Blood Culture (BC-GP) Nucleic Acid Test Cartridge

FDA UDI

LUMINEX CORPORATION·00840487101575·The Verigene® Gram-Positive Blood Culture Nucle...

Revogene® Carba C

FDA UDI

Meridian Bioscience Canada Inc·00628055344162·The Revogene® Carba C assay, performed on the R...

Gram-Positive Blood Culture (BC-GP) Utility Tray

FDA UDI

NANOSPHERE, INC.·00857573006287·The Verigene® Gram-Positive Blood Culture Nucle...

Gram-Positive Blood Culture (BC-GP) Utility Tray

FDA UDI

LUMINEX CORPORATION·00840487101674·The Verigene® Gram-Positive Blood Culture Nucle...

GenePOC™ Carba

FDA UDI

GenePoc Inc·00628055344070·The GenePOC™ Carba assay, performed on the revo...

Gram-Positive Blood Culture (BC-GP) Extraction Tray

FDA UDI

NANOSPHERE, INC.·00857573006218·The Verigene® Gram-Positive Blood Culture Nucle...

Revogene Carba C

FDA UDI

MERIDIAN BIOSCIENCE, INC.·00840733102370·The revogene Carba assay performed on the revog...

Gram-Positive Blood Culture (BC-GP) Extraction Tray

FDA UDI

LUMINEX CORPORATION·00840487101629·The Verigene® Gram-Positive Blood Culture Nucle...

Next Generation Sequencing Oncology Panel, Somatic Or Germline Variant Detection System

FDA Pre-Market Approval

FDA Class 3 ·Oncomine Dx Target Test

Adenosine Deaminase (ADA) Control

Basic UDI-DI

EU IVDD · Eu Ivd General ·Maccura Biotechnology Co., Ltd. ·1 device

Adenosine Deaminase (ADA) Calibrator

Basic UDI-DI

EU IVDD · Eu Ivd General ·Maccura Biotechnology Co., Ltd. ·1 device

FRED PA-1 DA

Basic UDI-DI

EU MDD · Eu Md Class 2b ·SCHILLER MEDICAL·1 device

Adenosine Deaminase (ADA) Control

Basic UDI-DI

EU IVDD · Eu Ivd General ·Maccura Biotechnology Co., Ltd. ·1 device

EL-ANA PROFILES: ANA/4

FDA UDI

THERA-TEST LABORATORIES, INC·00854473003293·ANTI-NUCLEAR ANTIBODY ELISA TEST KIT, 60 TESTS ...

EL-ANA PROFILES: ANA/4

FDA UDI

THERA-TEST LABORATORIES, INC·00854473003309·ANTI-NUCLEAR ANTIBODY ELISA TEST KIT, 24 TESTS ...

QIAstat-Dx® Respiratory Panel

FDA UDI

QIAGEN GmbH·04053228033905·