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

FDA Pre-Market Approval

FDA Class 3 ·HER2 FISH PHARMDX KIT

Implantable Pulse Generator, Pacemaker (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·CONTAK RENEWAL/3/3 HE/3 RF/LIVIAN RF1 SE/CONTAK RENEWAL 3 AVT/COGNIS

System, Test, Her-2/Neu, Ihc

FDA classification

FDA Class 3 ·System, Test, Her-2/Neu, Ihc

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

FDA classification

FDA Class 3 ·System, Test, Her-2/Neu, Nucleic Acid Or Serum

Warmer, Blood, Electromagnetic Radiation

FDA classification

FDA Class 3 ·Warmer, Blood, Electromagnetic Radiation

Monitor,Test,Hiv-1

FDA classification

FDA Class 3 ·Monitor,Test,Hiv-1

Molecular Erythrocyte Typing Test

FDA classification

FDA Class 3 ·Molecular Erythrocyte Typing Test

Antibody To Htlv-1, Elisa

FDA classification

FDA Class 3 ·Antibody To Htlv-1, Elisa

Mechanical And Enzymatic Autologous Skin Processor For Cell Suspension, With Applicator

FDA classification

FDA Class 3 ·Mechanical And Enzymatic Autologous Skin Processor For Cell Suspension, With Applicator

Mechanical And Enzymatic Autologous Skin Processor For Cell Suspension, For Stable Vitiligo, With Applicator

FDA classification

FDA Class 3 ·Mechanical And Enzymatic Autologous Skin Processor For Cell Suspension, For Stable Vitiligo, With Applicator

System, Separation, Hematopoietic Stem Cell

FDA classification

FDA Class 3 ·System, Separation, Hematopoietic Stem Cell

Kit, Test, Saliva, Hiv-1&2

FDA classification

FDA Class 3 ·Kit, Test, Saliva, Hiv-1&2

Illuminator System For Blood Products

FDA classification

FDA Class 3 ·Illuminator System For Blood Products

System, Test, Home, Hiv-1

FDA classification

FDA Class 3 ·System, Test, Home, Hiv-1

Pediatric Extracorporeal Synthetic Semipermeable Membrane Cartridge For Acute Kidney Injury

FDA classification

FDA Class 3 ·Pediatric Extracorporeal Synthetic Semipermeable Membrane Cartridge For Acute Kidney Injury

Kit, Sample Collection, Hiv

FDA classification

FDA Class 3 ·Kit, Sample Collection, Hiv

System, Identification, Hepatitis B Antigen

FDA classification

FDA Class 3 ·System, Identification, Hepatitis B Antigen

Kit, Assay, Estrogen Receptor

FDA classification

FDA Class 3 ·Kit, Assay, Estrogen Receptor

Immunohistochemistry Test, Dna Mismatch Repair (Mmr) Protein Assay

FDA classification

FDA Class 3 ·Immunohistochemistry Test, Dna Mismatch Repair (Mmr) Protein Assay

Immunocytochemistry Assay, P16/Ki-67

FDA classification

FDA Class 3 ·Immunocytochemistry Assay, P16/Ki-67