Access PCT

FDA 510(k)

FDA Class 2 ·Microbiology

Diazyme Procalcitonin (PCT) Assay, Diazyme Procalcitonin (PCT) Calibrator Set, Diazyme Procalcitonin (PCT) Control Set

FDA 510(k)

FDA Class 2 ·Microbiology

DiaSys Procalcitonin FS; DiaSys TruCal Procalcitonin Calibrator Set; DiaSys TruLab Procalcitonin Bi-Level Controls

FDA 510(k)

FDA Class 2 ·Microbiology

Access PCT, Access PCT Calibrators

FDA 510(k)

FDA Class 2 ·Microbiology

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

FDA Pre-Market Approval

FDA Class 2 ·COBAS HCV TEST

Colon Computed Tomography System, Computer Aided Detection

FDA classification

FDA Class 2 ·Colon Computed Tomography System, Computer Aided Detection

Calibrator, Hearing Aid / Earphone And Analysis Systems

FDA classification

FDA Class 2 ·Calibrator, Hearing Aid / Earphone And Analysis Systems

Brain Injury Adjunctive Interpretive Oculomotor Assessment Aid

FDA classification

FDA Class 2 ·Brain Injury Adjunctive Interpretive Oculomotor Assessment Aid

Lung Computed Tomography System, Computer-Aided Detection

FDA classification

FDA Class 2 ·Lung Computed Tomography System, Computer-Aided Detection

Brain Injury Adjunctive Interpretive Electroencephalograph Assessment Aid

FDA classification

FDA Class 2 ·Brain Injury Adjunctive Interpretive Electroencephalograph Assessment Aid

Self-Fitting Air-Conduction Hearing Aid, Prescription

FDA classification

FDA Class 2 ·Self-Fitting Air-Conduction Hearing Aid, Prescription

Analyzer, Medical Image

FDA Pre-Market Approval

FDA Class 2 ·LOGICON CARIES DETECTOR

Assay, Enzyme Linked Immunosorbent, Hepatitis C Virus

FDA Pre-Market Approval

FDA Class 2 ·ADVIA CENTAUR HCV READY PACK REAGENTS, ADVIA CENTAUR HCV QUALITY CONTROL MATERIALS

Cytomegalovirus (Cmv) Dna Quantitative Assay

FDA Pre-Market Approval

FDA Class 2 ·Aptima CMV Quant Assay

Hepatitis A Test (Antibody And Igm Antibody)

FDA Pre-Market Approval

FDA Class 2 ·ADVIA CENTAUR HAV TOTAL ASSAY, ADVIA CENTAUR HAV TOTAL QUALITY CONTROL MATERIALS

Assay, Enzyme Linked Immunosorbent, Hepatitis C Virus

FDA Pre-Market Approval

FDA Class 2 ·ELECSYS ANTI-HCV IMMUNOASSAY & ELECSYS PRECICONTROL ANTI-HCV FOR USE ON MODULAR ANALYTICS E170 IMMUNOSSAY ANALYZER

Assay, Enzyme Linked Immunosorbent, Hepatitis C Virus

FDA Pre-Market Approval

FDA Class 2 ·ELECSYS ANTI-HCV IMMUNOASSAY & ELECSYS PRECICONTROL ANTI-HCV FOR USE ON COBAS E601 IMMUNOSSAY ANALYZER

Hepatitis A Test (Antibody And Igm Antibody)

FDA Pre-Market Approval

FDA Class 2 ·ADVIA CENTAUR HAV IGM READY PACK REAGENTS, ADVIA CENTAUR HAV IGM QUALITY CONTROL MATERIALS

Hearing Aid, Air-Conduction With Wireless Technology, Prescription

FDA classification

FDA Class 2 ·Hearing Aid, Air-Conduction With Wireless Technology, Prescription

Bone Sonometer

FDA Pre-Market Approval

FDA Class 2 ·THE SUNLIGHT OMNISENSE(TM) ULTRASOUND BONE SONOMETER