Rickettsia Spp. Nucleic Acid Based Detection Assay

FDA classification

FDA Class 2 ·Rickettsia Spp. Nucleic Acid Based Detection Assay

Assay, Proliferation, In Vitro, T Lymphocyte

FDA classification

FDA Class 2 ·Assay, Proliferation, In Vitro, T Lymphocyte

Dengue Serological Reagents

FDA classification

FDA Class 2 ·Dengue Serological Reagents

System, Cystic Fibrosis Transmembrane Conductance Regulator, Gene Mutation Detection

FDA classification

FDA Class 2 ·System, Cystic Fibrosis Transmembrane Conductance Regulator, Gene Mutation Detection

Human Leukocyte Antigen (Hla) Typing Companion Diagnostic Test

FDA classification

FDA Class 2 ·Human Leukocyte Antigen (Hla) Typing Companion Diagnostic Test

Candida Species Nucleic Acid Detection System

FDA classification

FDA Class 2 ·Candida Species Nucleic Acid Detection System

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, V2.0

Tracheal Prosthesis With Cover Material Derived From Human Sources

FDA classification

FDA Class 2 ·Tracheal Prosthesis With Cover Material Derived From Human Sources

Closed Loop Auto Titration Device For Oral Appliances

FDA classification

FDA Class 2 ·Closed Loop Auto Titration Device For Oral Appliances

Spinal Muscular Atrophy Newborn Screening Test System

FDA classification

FDA Class 2 ·Spinal Muscular Atrophy Newborn Screening Test System

Artificial Chordae Tendineae Surgical Replacement System

FDA classification

FDA Class 2 ·Artificial Chordae Tendineae Surgical Replacement System

Sub-Scalp Implanted Electroencephalogram System For Remote Patient Monitoring

FDA classification

FDA Class 2 ·Sub-Scalp Implanted Electroencephalogram System For Remote Patient Monitoring

System, Cystic Fibrosis Transmembrane Conductance Regulator Gene, Mutations & Variants Panel Sequencing Detection

FDA classification

FDA Class 2 ·System, Cystic Fibrosis Transmembrane Conductance Regulator Gene, Mutations & Variants Panel Sequencing Detection

Multiplex Immunoassay For Measles Virus, Mumps Virus, Rubella And Varicella Zoster Virus

FDA classification

FDA Class 2 ·Multiplex Immunoassay For Measles Virus, Mumps Virus, Rubella And Varicella Zoster Virus

System, Cystic Fibrosis Transmembrane Conductance Regulator Gene, Variant Gene Sequence Detection

FDA classification

FDA Class 2 ·System, Cystic Fibrosis Transmembrane Conductance Regulator Gene, Variant Gene Sequence Detection

Automated Digital Image Manual Interpretation Microscope

FDA classification

FDA Class 2 ·Automated Digital Image Manual Interpretation Microscope

Bone Sonometer

FDA classification

FDA Class 2 ·Bone Sonometer

Novel Influenza A Virus, A/H5 Ns1 Protein

FDA classification

FDA Class 2 ·Novel Influenza A Virus, A/H5 Ns1 Protein

Assay, Enzyme Linked Immunosorbent, Hepatitis C Virus

FDA Pre-Market Approval

FDA Class 2 ·ARCHITECT ANTI-HCV ASSAY; ARCHITECT ANTI-HCV CALIBRATOR; ARCHITECT ANTI-HCV CONTROL

Forceps, Biopsy, Electric, Reprocessed

FDA classification

FDA Class 2 ·Forceps, Biopsy, Electric, Reprocessed