Cytomegalovirus (Cmv) Dna Quantitative Assay

FDA Pre-Market Approval

FDA Class 2 ·Abbott RealTime CMV Amplification Kit (09N21-090), Abbott RealTime CMV Control Kit (09N21-080), Abbott RealTime CMV Cali

System, Test, Her-2/Neu, Nucleic Acid Or Serum

FDA Pre-Market Approval

FDA Class 3 ·PATHVYSION HER-2 DNA PROBE KIT

Lens, Contact (Polymethylmethacrylate)

FDA Pre-Market Approval

FDA Unclassified ·CABCURVE (POROFOCAN B)

Test, Fluorescence In Situ Hybridization (Fish), For Bladder Cancer Detection And Monitoring For Recurrence

FDA Pre-Market Approval

FDA Class 3 ·UROVYSION BLADDER CANCER KIT

Somatic Gene Mutation Detection System

FDA Pre-Market Approval

FDA Class 3 ·Abbott RealTime IDH2

Lens, Contact (Polymethylmethacrylate)

FDA Pre-Market Approval

FDA Unclassified ·POLYCON CONTACT LENS

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

FDA Pre-Market Approval

FDA Class 2 ·Alinity m HCV

Lens, Contact (Polymethylmethacrylate)

FDA Pre-Market Approval

FDA Unclassified ·SATURN II(TM) (SYNERGICON A) CONTACT LENS

Hepatitis Viral B Dna Detection

FDA Pre-Market Approval

FDA Class 3 ·ABBOTT REALTIME HBV ASSAY

Lens, Contact (Polymethylmethacrylate)

FDA Pre-Market Approval

FDA Unclassified ·CABCURVE (POROFOCAN B)

Lens, Contact (Other Material) - Daily

FDA Pre-Market Approval

FDA Class 2 ·OPUS - III CONTACT LENSES

Lens, Contact (Polymethylmethacrylate)

FDA Pre-Market Approval

FDA Unclassified ·POLYCON CONTACT LENS

Lens, Contact (Polymethylmethacrylate)

FDA Pre-Market Approval

FDA Unclassified ·POLYCON CONTACT LENS

Lens, Contact (Polymethylmethacrylate)

FDA Pre-Market Approval

FDA Unclassified ·CABCURVE CONTACT LENS (POROFOCON B)

Fluorescence In Situ Hybridization, Anaplastic Lymphoma Kinase, Gene Rearrangement

FDA Pre-Market Approval

FDA Class 3 ·Vysis ALK Break Apart FISH Probe Kit

Fluorescence In Situ Hybridization, Chromosome 17p Deletion (Tp53)

FDA Pre-Market Approval

FDA Class 3 ·VYSIS CLL FISH PROBE KIT

Somatic Gene Mutation Detection System

FDA Pre-Market Approval

FDA Class 3 ·Abbott RealTime IDH1

Hepatitis Viral B Dna Detection

FDA Pre-Market Approval

FDA Class 3 ·ABBOTT REAL TIME HBV

System, Test, Her-2/Neu, Nucleic Acid Or Serum

FDA Pre-Market Approval

FDA Class 3 ·PathVysion HER-2 DNA Probe Kit

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

FDA Pre-Market Approval

FDA Class 2 ·ABBOTT REALTIME HCV