203 results · 44ms · Sources: EU EUDAMED, US FDA

Planet Innovation Products, Inc.

FDA registration
Planet Innovation Products, Inc.·1 product·🇺🇸 United States

Alethia CMV Assay Test System

FDA registration
MERIDIAN BIOSCIENCE, INC.·1 product·🇺🇸 United States

Alethia™ CMV

FDA UDI
MERIDIAN BIOSCIENCE, INC.·00840733102080·The Alethia CMV Assay Test System includes sepa...

Alethia™ CMV External Control Kit

FDA UDI
MERIDIAN BIOSCIENCE, INC.·00840733102097·The Alethia™ CMV External Control Kit contains ...

MOL2255 - Simplexa Congenital CMV Direct

FDA registration
DiaSorin Molecular LLC·2 products·🇺🇸 United States

Simplexa Congenital CMV Direct

FDA UDI
DIASORIN MOLECULAR LLC·20816101025835·

Simplexa Congenital CMV Positive Control Pack

FDA UDI
DIASORIN MOLECULAR LLC·20816101025842·

Simplexa Congenital CMV Direct and Simplexa Congenital CMV Positive Control Pack

FDA 510(k)
FDA Class 2 ·Microbiology

Alethia CMV DNA Amplification Assay, Alethia CMV External Control Kit

FDA 510(k)
FDA Class 2 ·Microbiology

Qualitative Cytomegalovirus Nucleic Acid-Based Detection Device For Congenital Cytomegalovirus Infection

FDA classification
FDA Class 2 ·Qualitative Cytomegalovirus Nucleic Acid-Based Detection Device For Congenital Cytomegalovirus Infection

Aptima CMV Quant Target Enhancer Reagent Box

FDA registration
Hologic, Inc.·1 product·🇺🇸 United States

KIT COBAS 6800/8800 CMV RMC IVD

FDA registration
ROCHE DIAGNOSTICS INTERNATIONAL LTD.·1 product·🇨🇭 Switzerland

KIT COBAS 6800/8800 CMV RMC IVD

FDA registration
ROCHE MOLECULAR SYSTEMS, INC.·1 product·🇺🇸 United States

COBAS AmpliPrep/COBAS TaqMan CMV Test

FDA registration
ROCHE MOLECULAR SYSTEMS, INC.·1 product·🇺🇸 United States

COBAS AmpliPrep/COBAS TaqMan CMV Test

FDA registration
ROCHE MOLECULAR SYSTEMS, INC.·1 product·🇺🇸 United States

KIT COBAS 6800/8800 CMV RMC IVD

FDA registration
ROCHE DIAGNOSTICS GMBH·1 product·🇩🇪 Germany

Abbott RealTime CMV m2000 System ROW Combined Application CD-ROM (5N23-01)

FDA registration
ABBOTT MOLECULAR, INC.·1 product·🇺🇸 United States

KIT CAP-G/CTM CMV 72 TESTS CE-IVD

FDA registration
ROCHE MOLECULAR SYSTEMS, INC.·1 product·🇺🇸 United States

Alinity m Lysis Solution

FDA registration
RPI BIOSOLUTIONS·1 product·🇺🇸 United States

KIT COBAS 6800/8800 CMV RMC IVD

FDA registration
ROCHE MOLECULAR SYSTEMS, INC.·1 product·🇺🇸 United States