599 results · 21ms · Sources: EU EUDAMED, US FDA

Xpert® FII & FV

FDA 510(k)
FDA Class 2 ·Hematology

INVADER MTHFR 1298

FDA 510(k)
FDA Class 2 ·Hematology

WAKO LBA DCP TEST SYSTEM, MODEL 993-05301; DCP CONTROL SET, MODEL 995-0551; DCP CALIBRATOR SET, LIBASYS, MODEL 999-05401

FDA 510(k)
FDA Class 2 ·Immunology

INVADER MTHFR 677

FDA 510(k)
FDA Class 2 ·Hematology

Adaptive Biotechnologies clonoSEQ Assay

FDA 510(k)
FDA Class 2 ·Pathology

Adaptive Biotechnologies clonoSEQ Assay

FDA 510(k)
FDA Class 2 ·Pathology

CEP X SPECTRUMORANGE\Y SPECTRUMGREEN DNA PROBE KIT

FDA 510(k)
FDA Class 2 ·Immunology

Cytomegalovirus (Cmv) Dna Quantitative Assay

FDA Pre-Market Approval
FDA Class 2 ·Cobas CMV

Cytomegalovirus (Cmv) Dna Quantitative Assay

FDA Pre-Market Approval
FDA Class 2 ·cobas CMV

Cytomegalovirus (Cmv) Dna Quantitative Assay

FDA Pre-Market Approval
FDA Class 2 ·Alinity m CMV Assay

Cytomegalovirus (Cmv) Dna Quantitative Assay

FDA Pre-Market Approval
FDA Class 2 ·COBAS® AmpliPrep/ COBAS® TaqMan® CMV Test

Cytomegalovirus (Cmv) Dna Quantitative Assay

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

Cytomegalovirus (Cmv) Dna Quantitative Assay

FDA Pre-Market Approval
FDA Class 2 ·COBAS CMV

Cytomegalovirus (Cmv) Dna Quantitative Assay

FDA Pre-Market Approval
FDA Class 2 ·Alinity m CMV

Cytomegalovirus (Cmv) Dna Quantitative Assay

FDA Pre-Market Approval
FDA Class 2 ·COBAS AMPLIPREP/COBAS TAQMAN CYTOMEGALOVIRUS TEST

Cytomegalovirus (Cmv) Dna Quantitative Assay

FDA Pre-Market Approval
FDA Class 2 ·COBAS AmpliPrep/COBAS TaqMan CMV Test

Cytomegalovirus (Cmv) Dna Quantitative Assay

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

Cytomegalovirus (Cmv) Dna Quantitative Assay

FDA Pre-Market Approval
FDA Class 2 ·cobas CMV Test for use on the cobas 6800/8800 System

Cytomegalovirus (Cmv) Dna Quantitative Assay

FDA Pre-Market Approval
FDA Class 2 ·cobas CMV

Cytomegalovirus (Cmv) Dna Quantitative Assay

FDA Pre-Market Approval
FDA Class 2 ·ABBOTT REALTIME CMV