Hepatitis A Test (Antibody And Igm Antibody)

FDA Pre-Market Approval

FDA Class 2 ·DIASORIN ETI-AB-HAVK PLUS

MODEL 102 PH METER

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

CYTO-STAT CD3-FITC/CD56-RDI MONOCLONAL ANTIBODY REAGENT WITH CYTO-STAT/COULTER CLONE MSIGGI-RD1/MSIGGI-FITC ISOTYPIC COL

FDA 510(k)

FDA Class 2 ·Hematology

Device To Detect And Identify Selected Microbial Agents That Cause Acute Febrile Illness

FDA classification

FDA Class 2 ·Device To Detect And Identify Selected Microbial Agents That Cause Acute Febrile Illness

FilmArray Global Fever Panel

FDA 510(k)

FDA Class 2 ·Microbiology

BIOFIRE FILMARRAY Tropical Fever Panel

FDA 510(k)

FDA Class 2 ·Microbiology

BioFire Global Fever Panel, BIOFIRE SHIELD Control Kit for the BioFire Global Fever Panel

FDA 510(k)

FDA Class 2 ·Microbiology

Strip, Dialysate, Ph, Bicarbonate, Glucose, Acid, Indicator

FDA classification

FDA Class 2 ·Strip, Dialysate, Ph, Bicarbonate, Glucose, Acid, Indicator

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

Antigen, Ha (Including Ha Control), Rubella

FDA classification

FDA Class 2 ·Antigen, Ha (Including Ha Control), Rubella

Free Radical Assay, Lsd

FDA classification

FDA Class 2 ·Free Radical Assay, Lsd

Analyzer, Ion, Hydrogen-Ion (Ph), Blood-Phase, Indwelling

FDA classification

FDA Class 2 ·Analyzer, Ion, Hydrogen-Ion (Ph), Blood-Phase, Indwelling

Electrode, Ion Specific, Sodium

FDA classification

FDA Class 2 ·Electrode, Ion Specific, Sodium

Electrode, Ion Specific, Potassium

FDA classification

FDA Class 2 ·Electrode, Ion Specific, Potassium

Electrode, Ion-Specific, Chloride

FDA classification

FDA Class 2 ·Electrode, Ion-Specific, Chloride

Electrode, Ion Specific, Calcium

FDA classification

FDA Class 2 ·Electrode, Ion Specific, Calcium

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