Test, Hepatitis B (B Core, Be Antigen, Be Antibody, B Core Igm)

FDA Pre-Market Approval

FDA Class 3 ·VITROS IMMUNODIAGNOSTIC PRODUCT HBSAG REAGENT PACK & CALIBRATOR & VITROS IMMUNODIAGNOSTIC PRODUCTS HBSAG CONFIRMATORY KI

Kit, Rna Detection, Human Papillomavirus

FDA Pre-Market Approval

FDA Class 3 ·APTIMA HPV ASSAY

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

Automated Insulin Dosing Device System, Single Hormonal Control

FDA Pre-Market Approval

FDA Class 3 ·MiniMed 670G System

Automated Insulin Dosing Device System, Single Hormonal Control

FDA Pre-Market Approval

FDA Class 3 ·MiniMed 670G System

Implant, Intragastric For Morbid Obesity

FDA Pre-Market Approval

FDA Class 3 ·Obalon Balloon System

Test, Hepatitis B (B Core, Be Antigen, Be Antibody, B Core Igm)

FDA Pre-Market Approval

FDA Class 3 ·ARCHITECT HBSAG QUALITATIVE, QUALITATIVE CONFIRMATORY, CONFIRMATORY MANUAL DILUENT, CALIBRATORS, AND CONTROLS

Kit, Dna Detection, Human Papillomavirus

FDA Pre-Market Approval

FDA Class 3 ·CERVISTA HPV 16/18