Enzymatic Radiochemical Assay, Tobramycin

FDA classification

FDA Class 2 ·Enzymatic Radiochemical Assay, Tobramycin

Acid, Uric, Uricase (U.V.)

FDA classification

FDA Class 1 ·Acid, Uric, Uricase (U.V.)

Myoglobin, Rhodamine, Antigen, Antiserum, Control

FDA classification

FDA Class 2 ·Myoglobin, Rhodamine, Antigen, Antiserum, Control

Ldt, Approved By Nys Clep

FDA classification

FDA Not Classified ·Ldt, Approved By Nys Clep

Ldl & Vldl Precipitation, Hdl

FDA classification

FDA Class 1 ·Ldl & Vldl Precipitation, Hdl

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

Low-Density Lipoprotein (Ldl) Cholesterol Sub-Fraction Test

FDA classification

FDA Class 1 ·Low-Density Lipoprotein (Ldl) Cholesterol Sub-Fraction Test

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

Ldt, Unmet Need Within An Integrated Healthcare System

FDA classification

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

Ldl & Vldl Precipitation, Cholesterol Via Esterase-Oxidase, Hdl

FDA classification

FDA Class 1 ·Ldl & Vldl Precipitation, Cholesterol Via Esterase-Oxidase, Hdl

Light Adjustable Lens (Lal) And Light Delivery Device (Ldd)

FDA classification

FDA Class 3 ·Light Adjustable Lens (Lal) And Light Delivery Device (Ldd)

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

Adhesive Backed Thermal Skin Patches

FDA classification

FDA Class 1 ·Adhesive Backed Thermal Skin Patches

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

Ataxiagraph

FDA classification

FDA Class 1 ·Ataxiagraph

Ldt, Non-Molecular Antisera For Rare Rbc Antigens When There Is No Alternative Ivd

FDA classification

FDA Not Classified ·Ldt, Non-Molecular Antisera For Rare Rbc Antigens When There Is No Alternative Ivd

Foley Catheters And Accessories With Additional Safety Features

FDA classification

FDA Class 2 ·Foley Catheters And Accessories With Additional Safety Features

Aortic Valve, Prosthesis, Percutaneously Delivered

FDA classification

FDA Class 3 ·Aortic Valve, Prosthesis, Percutaneously Delivered

Pulmonary Valve Prosthesis Percutaneously Delivered

FDA classification

Pulmonary Valve Prosthesis Percutaneously Delivered

Prosthesis, Mitral Valve, Percutaneously Delivered

FDA classification

FDA Class 3 ·Prosthesis, Mitral Valve, Percutaneously Delivered