Sepsis ImmunoScore

FDA 510(k)

FDA Class 2 ·General Hospital

Medical Non-Ablative Fractional Laser Systems

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

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

Software Device To Aid In The Prediction Or Diagnosis Of Sepsis

FDA classification

FDA Class 2 ·Software Device To Aid In The Prediction Or Diagnosis Of Sepsis

Assay To Measure Pct To Aid In The Risk Assessment Of Critically Ill Patients On Their First Day Of Icu Admission

FDA classification

FDA Class 2 ·Assay To Measure Pct To Aid In The Risk Assessment Of Critically Ill Patients On Their First Day Of Icu Admission

Rinse, Oral, Antibacterial (By Physical Means)

FDA classification

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

Enzyme Linked Immunoabsorbent Assay, Antibody, B. Anthracis

FDA classification

FDA Class 2 ·Enzyme Linked Immunoabsorbent Assay, Antibody, B. Anthracis

Diagnostic Light, Soft Tissue Detector

FDA classification

FDA Class 2 ·Diagnostic Light, Soft Tissue Detector

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

Automatic Event Detection Software For Full-Montage Electroencephalograph

FDA classification

FDA Class 2 ·Automatic Event Detection Software For Full-Montage Electroencephalograph

Organophosphate Test System

FDA classification

FDA Class 2 ·Organophosphate Test System

Simple In Vitro Diagnostic Device For The Detection Of Secreted Proteins From Bacillus Spp. In Human Clinical Samples

FDA classification

FDA Class 2 ·Simple In Vitro Diagnostic Device For The Detection Of Secreted Proteins From Bacillus Spp. In Human Clinical Samples

System, Mass Spectrometry, Multiplex Genotyping, Hereditary Thrombophilia Related Mutations

FDA classification

FDA Class 2 ·System, Mass Spectrometry, Multiplex Genotyping, Hereditary Thrombophilia Related Mutations

Bacteriophage And Controls, B. Anthracis Lysis

FDA classification

FDA Class 2 ·Bacteriophage And Controls, B. Anthracis Lysis

Automatic Event Detection Software For Polysomnograph With Electroencephalograph

FDA classification

FDA Class 2 ·Automatic Event Detection Software For Polysomnograph With Electroencephalograph

Automated Indirect Immunofluorescence Microscope And Software-Assisted System For Clinical Use

FDA classification

FDA Class 2 ·Automated Indirect Immunofluorescence Microscope And Software-Assisted System For Clinical Use

Flow Cytometric Reagents And Accessories.

FDA classification

FDA Class 2 ·Flow Cytometric Reagents And Accessories.