Electrode, Pacemaker, Temporary

FDA classification

FDA Class 2 ·Electrode, Pacemaker, Temporary

Prothrombin, Antigen, Antiserum, Control

FDA classification

FDA Class 1 ·Prothrombin, Antigen, Antiserum, Control

Acid, Vanilmandelic, Diazo, P-Nitroaniline/Vanillin

FDA classification

FDA Class 1 ·Acid, Vanilmandelic, Diazo, P-Nitroaniline/Vanillin

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

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

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

FDA classification

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

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

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

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

System, Balloon, Intra-Aortic And Control, Reprocessed

FDA classification

FDA Class 3 ·System, Balloon, Intra-Aortic And Control, Reprocessed

Catheter, Oximeter, Fiber Optic, Reprocessed

FDA classification

FDA Class 2 ·Catheter, Oximeter, Fiber Optic, Reprocessed

Trocar, Reprocessed

FDA classification

FDA Class 2 ·Trocar, Reprocessed

Bur, Diamond Coated, Reprocessed

FDA classification

FDA Class 1 ·Bur, Diamond Coated, Reprocessed

Biopsy Device, Percutaneous, Reprocessed

FDA classification

FDA Class 1 ·Biopsy Device, Percutaneous, Reprocessed

Needle And Needle Set, Gastro-Urology, Reprocessed

FDA classification

FDA Class 2 ·Needle And Needle Set, Gastro-Urology, Reprocessed