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, ABBOTT REALTIME HCV AMPLIFICATION REAGENT KIT, ABBOTT REALTIME HVC CONTROL KIT, ABBOTT REALTIME HCV

Menopause Test System

FDA classification

FDA Class 2 ·Menopause Test System

Autoantibodies, Glutamic Acid Decarboxylase (Gad)

FDA classification

FDA Class 2 ·Autoantibodies, Glutamic Acid Decarboxylase (Gad)

Joint Biological Agent Identification And Diagnostic System (Jbaids) Tularemia Detection Kit

FDA classification

FDA Class 2 ·Joint Biological Agent Identification And Diagnostic System (Jbaids) Tularemia Detection Kit

Tyrosine Phosphatase (Ia-2) Autoantibody Assay

FDA classification

FDA Class 2 ·Tyrosine Phosphatase (Ia-2) Autoantibody Assay

Muscular Dystrophy Newborn Screening Test

FDA classification

FDA Class 2 ·Muscular Dystrophy Newborn Screening Test

System, Nucleic Acid Amplification Test, Dna, Methicillin Resistant Staphylococcus Aureus, Direct Specimen

FDA classification

FDA Class 2 ·System, Nucleic Acid Amplification Test, Dna, Methicillin Resistant Staphylococcus Aureus, Direct Specimen

Autoantibodies, Anti-Soluble Liver Antigen (Sla), Autoimmune Hepatitis

FDA classification

FDA Class 2 ·Autoantibodies, Anti-Soluble Liver Antigen (Sla), Autoimmune Hepatitis

Trichomonas Vaginalis Nucleic Acid Amplification Test System

FDA classification

FDA Class 2 ·Trichomonas Vaginalis Nucleic Acid Amplification Test System

Diagnostic Light, Soft Tissue Detector

FDA classification

FDA Class 2 ·Diagnostic Light, Soft Tissue Detector

Alpha-1-Antitrypsin Kit, Qualitative Phenotype

FDA classification

FDA Class 2 ·Alpha-1-Antitrypsin Kit, Qualitative Phenotype

Nucleic Acid Amplification, Novel Influenza A Virus, A/H5 (Asian Lineage) Rna

FDA classification

FDA Class 2 ·Nucleic Acid Amplification, Novel Influenza A Virus, A/H5 (Asian Lineage) Rna

Antibodies, Anti-Actin, Anti-Smooth Muscle

FDA classification

FDA Class 2 ·Antibodies, Anti-Actin, Anti-Smooth Muscle

Barrier, Synthetic, Intraoral

FDA classification

FDA Class 2 ·Barrier, Synthetic, Intraoral

Insulin Autoantibody Kit

FDA classification

FDA Class 2 ·Insulin Autoantibody Kit

Embryo Image Assessment System, Assisted Reproduction

FDA classification

FDA Class 2 ·Embryo Image Assessment System, Assisted Reproduction

Anti-Glutamate Receptor (Type Nmda) Ifa

FDA classification

FDA Class 2 ·Anti-Glutamate Receptor (Type Nmda) Ifa

Mycophenolic Acid Test System

FDA classification

FDA Class 2 ·Mycophenolic Acid Test System

Rinse, Oral, Antibacterial (By Physical Means)

FDA classification

FDA Class 2 ·Rinse, Oral, Antibacterial (By Physical Means)

Percutaneous, Implanted, Long-Term Intravascular Catheter Accessory For Catheter Position

FDA classification

FDA Class 2 ·Percutaneous, Implanted, Long-Term Intravascular Catheter Accessory For Catheter Position