3,214 results · 39ms · Sources: EU EUDAMED, US FDA

MDI DS-DNA TEST

FDA 510(k)
FDA Class 2 ·Immunology

VARELISA SSDNA ANTIBODIES, MODEL 14896

FDA 510(k)
FDA Class 2 ·Immunology

SERAQUEST ANTI-DSDNA

FDA 510(k)
FDA Class 2 ·Immunology

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

Assay, Hybridization And/Or Nucleic Acid Amplification For Detection Of Hepatitis C Rna,Hepatitis C Virus

FDA Pre-Market Approval
FDA Class 2 ·ROCHE MOLECULAR SYSTEMS COBAS AMPLIPREP/COBAS AMPLICOR HCV TEST

Cytomegalovirus (Cmv) Dna Quantitative Assay

FDA Pre-Market Approval
FDA Class 2 ·ARTUS CMV RGQ MDX KIT

ESENOR FII-FV-MTHFR GENOTYPING TEST, ESENOR FII-FV GENOTYPING TEST, ESENOR FII GENOTYPING

FDA 510(k)
FDA Class 2 ·Hematology

INVADER FACTOR II

FDA 510(k)
FDA Class 2 ·Hematology

cobas Factor II and Factor V Test

FDA 510(k)
FDA Class 2 ·Hematology

VERIFY ASSERT STEAM Process Challenge Device

FDA 510(k)
FDA Class 2 ·General Hospital

VERIFY CRONOS SELF-CONTAINED BIOLOGICAL INDICATOR

FDA 510(k)
FDA Class 2 ·General Hospital

Xpert® FII & FV

FDA 510(k)
FDA Class 2 ·Hematology

FACTOR V LEIDEN KIT

FDA 510(k)
FDA Class 2 ·Hematology

VERIFY Incubator for Assert Self Contained Biological Indicators

FDA 510(k)
FDA Class 2 ·General Hospital

INFINITI SYSTEM

FDA 510(k)
FDA Class 2 ·Hematology

RNARETAIN

FDA 510(k)
FDA Class 2 ·Immunology

INVADER FACTOR V

FDA 510(k)
FDA Class 2 ·Hematology

VERIFY Assert Self-Contained Biological Indicator

FDA 510(k)
FDA Class 2 ·General Hospital

FACTOR II (PROTHROMBIN) G20210A KIT

FDA 510(k)
FDA Class 2 ·Hematology

VERIFY Assert Self-Contained Biological Indicator

FDA 510(k)
FDA Class 2 ·General Hospital