955 results
·
167ms
·
Sources: EU EUDAMED, US FDA
cobas® SARS-CoV-2 Qualitative Control Kit
FDA registration
ROCHE MOLECULAR SYSTEMS, INC.·1 product·🇺🇸 United States
LightCycler version 1.2 Instrument
FDA registration
ROCHE MOLECULAR SYSTEMS, INC.·1 product·🇺🇸 United States
cobas® liat CT/NG/MG nucleic acid test
FDA registration
ROCHE MOLECULAR SYSTEMS, INC.·3 products·🇺🇸 United States
cobas liat SARS-CoV-2 & Influenza A/B v2 nucleic acid test
FDA registration
ROCHE MOLECULAR SYSTEMS, INC.·1 product·🇺🇸 United States
KIT DNA ISOLATION 24T IVD
FDA registration
ROCHE MOLECULAR SYSTEMS, INC.·1 product·🇺🇸 United States
cobas vivoDx system
FDA registration
ROCHE MOLECULAR SYSTEMS, INC.·1 product·🇺🇸 United States
cobas® EZH2 Mutation Test
FDA registration
ROCHE MOLECULAR SYSTEMS, INC.·1 product·🇺🇸 United States
COBAS TaqMan 48 Analyzer
FDA registration
ROCHE MOLECULAR SYSTEMS, INC.·1 product·🇺🇸 United States
Opulus Lymphoma Precision
FDA registration
ROCHE MOLECULAR SYSTEMS, INC.·1 product·🇺🇸 United States
SARS-CoV-2 & Influenza A/B for use on the Liat System
FDA registration
ROCHE MOLECULAR SYSTEMS, INC.·1 product·🇺🇸 United States
Ionify iDIL cobas i
FDA registration
ROCHE MOLECULAR SYSTEMS, INC.·1 product·🇺🇸 United States
cobas z480 Analyzer
FDA registration
ROCHE MOLECULAR SYSTEMS, INC.·1 product·🇺🇸 United States
cobas Cdiff Positive and Negative Control Kit for use on the cobas Liat System
FDA registration
ROCHE MOLECULAR SYSTEMS, INC.·2 products·🇺🇸 United States
KIT COBAS 4800 HSV 1/2 CONTROLS IVD
FDA registration
ROCHE MOLECULAR SYSTEMS, INC.·1 product·🇺🇸 United States
Kit, Dna Detection, Human Papillomavirus
FDA Pre-Market Approval
FDA Class 3
·COBAS HPV TEST
Kit, Dna Detection, Human Papillomavirus
FDA Pre-Market Approval
FDA Class 3
·COBAS HPV TEST
Hepatitis Viral B Dna Detection
FDA Pre-Market Approval
FDA Class 3
·COBAS TAQMAN HBV TEST FOR USE WITH THE HIGH PURE SYSTEM AND COBAS AMPLIPREP/COBAS TAQMAN HBV TEST V2.0
Assay, Hybridization And/Or Nucleic Acid Amplification For Detection Of Hepatitis C Rna,Hepatitis C Virus
FDA Pre-Market Approval
FDA Class 2
·COBAS AMPLIPREP / COBAS AMPLICOR HCV V2.0 AND COBAS AMPLICOR HCV TEST, V2.0
Assay, Hybridization And/Or Nucleic Acid Amplification For Detection Of Hepatitis C Rna,Hepatitis C Virus
FDA Pre-Market Approval
FDA Class 2
·COBAS AMPLIPREP/COBAS TAQMAN HCV TEST AND COBAS TAQMAN HCV TEST
Hepatitis Viral B Dna Detection
FDA Pre-Market Approval
FDA Class 3
·COBAS AMPLIPREP/COBAS TAQMAN HBV TEST V2.0 AND COBAS TAQMAN HBV TEST