Sofia 2 SARS Antigen+ FIA, Sofia 2 SARS Antigen+ FIA Control Swab Set

FDA 510(k)

FDA Class 2 ·Microbiology

Nano-Check™ COVID-19 Antigen Test

FDA 510(k)

FDA Class 2 ·Microbiology

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

Ph Meter For Dialysis Hydrogen Ion Concentration

FDA classification

FDA Class 2 ·Ph Meter For Dialysis Hydrogen Ion Concentration

Blood, Occult, Colorimetric, In Urine

FDA classification

FDA Class 2 ·Blood, Occult, Colorimetric, In Urine

Galectin-3 In Vitro Diagnostic Assay

FDA classification

FDA Class 2 ·Galectin-3 In Vitro Diagnostic Assay

System, In-Office Tinting, Contact Lenses

FDA classification

FDA Class 2 ·System, In-Office Tinting, Contact Lenses

Assay, Proliferation, In Vitro, T Lymphocyte

FDA classification

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

In Situ Polymerizing Peripheral Nerve Cap

FDA classification

FDA Class 2 ·In Situ Polymerizing Peripheral Nerve Cap

Blood, Occult, Enzymatic Method, In Urine

FDA classification

FDA Class 2 ·Blood, Occult, Enzymatic Method, In Urine

Test, Residual, Wbc In Leukoreduced Blood

FDA classification

FDA Class 2 ·Test, Residual, Wbc In Leukoreduced Blood

Check Valve, Retrograde Flow (In-Line)

FDA classification

FDA Class 2 ·Check Valve, Retrograde Flow (In-Line)

Heparin Flush In 0.45% Sodium Chloride

FDA classification

FDA Class 2 ·Heparin Flush In 0.45% Sodium Chloride

Sensor, Blood-Gas, In-Line, Cardiopulmonary Bypass

FDA classification

FDA Class 2 ·Sensor, Blood-Gas, In-Line, Cardiopulmonary Bypass

Media, Potentiating For In Vitro Diagnostic Use

FDA classification

FDA Class 2 ·Media, Potentiating For In Vitro Diagnostic Use

Cpb Check Valve, Retrograde Flow, In-Line

FDA classification

FDA Class 2 ·Cpb Check Valve, Retrograde Flow, In-Line

Laser, Microsurgical Argon, For Use In Otology

FDA classification

FDA Class 2 ·Laser, Microsurgical Argon, For Use In Otology