Fluorescent Immunoassay, Primidone

FDA classification

FDA Class 2 ·Fluorescent Immunoassay, Primidone

Left Atrial Appendage Clip, Implantable

FDA classification

FDA Class 2 ·Left Atrial Appendage Clip, Implantable

Antigen, Cf, T. Cruzi

FDA classification

FDA Class 1 ·Antigen, Cf, T. Cruzi

Radioimmunoassay, Prolactin (Lactogen)

FDA classification

FDA Class 1 ·Radioimmunoassay, Prolactin (Lactogen)

Igm, Antigen, Antiserum, Control

FDA classification

FDA Class 2 ·Igm, Antigen, Antiserum, Control

Temporary Non-Roller Type Left Heart Support Blood Pump

FDA classification

FDA Class 3 ·Temporary Non-Roller Type Left Heart Support Blood Pump

Ldt, Approved By Nys Clep

FDA classification

FDA Not Classified ·Ldt, Approved By Nys Clep

System, Appendage Closure, Left Atrial

FDA classification

FDA Class 3 ·System, Appendage Closure, Left Atrial

Leadless Cardiac Resynchronization Therapy (Crt)

FDA classification

FDA Class 3 ·Leadless Cardiac Resynchronization Therapy (Crt)

Ivd Offered As Ldt, Not An Ldt Or Under A Targeted Enforcement Discretion Policy Described In Preamble To Ldt Final Rule

FDA classification

FDA Not Classified ·Ivd Offered As Ldt, Not An Ldt Or Under A Targeted Enforcement Discretion Policy Described In Preamble To Ldt Final Rule

Left Ventricular Ejection Fraction Screening Tool

FDA classification

FDA Not Classified ·Left Ventricular Ejection Fraction Screening Tool

Absorbable Synthetic Wound Dressing

FDA classification

FDA Unclassified ·Absorbable Synthetic Wound Dressing

Temporary Non-Roller Type Left Or Right Heart Support Blood Pump

FDA classification

FDA Not Classified ·Temporary Non-Roller Type Left Or Right Heart Support Blood Pump

Ldt, Not Under A Targeted Enforcement Discretion Policy Described In Preamble To Ldt Final Rule

FDA classification

FDA Not Classified ·Ldt, Not Under A Targeted Enforcement Discretion Policy Described In Preamble To Ldt Final Rule

Pediatric Ventricular Assist Device

FDA classification

Pediatric Ventricular Assist Device

Ventricular Bypass (Assist) Device

FDA classification

FDA Class 3 ·Ventricular Bypass (Assist) Device

Ldt, Unmet Need Within An Integrated Healthcare System

FDA classification

FDA Not Classified ·Ldt, Unmet Need Within An Integrated Healthcare System

Drug Eluting Permanent Left Ventricular (Lv) Pacemaker Electrode

FDA classification

FDA Class 3 ·Drug Eluting Permanent Left Ventricular (Lv) Pacemaker Electrode

Modified Version Of Another Manufacturer’S Fda-Authorized Test Within Scope Described In Preamble To Ldt Final Rule

FDA classification

FDA Not Classified ·Modified Version Of Another Manufacturer’S Fda-Authorized Test Within Scope Described In Preamble To Ldt Final Rule

Ivd Offered As Ldt, First Marketed Before May 6, 2024, Not Modified Beyond Scope Described In Preamble To Ldt Final Rule

FDA classification

FDA Not Classified ·Ivd Offered As Ldt, First Marketed Before May 6, 2024, Not Modified Beyond Scope Described In Preamble To Ldt Final Rule