Kit, Earmold, Impression

FDA classification

FDA Class 1 ·Kit, Earmold, Impression

Sealant, Dural

FDA classification

FDA Class 3 ·Sealant, Dural

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

FDA classification

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

Fixation, Vision Training, Binocular

FDA classification

FDA Class 1 ·Fixation, Vision Training, Binocular

Transferrin, Antigen, Antiserum, Control

FDA classification

FDA Class 2 ·Transferrin, Antigen, Antiserum, Control

Chromatography Separation/Zimmerman 17-Ketogenic Steroids

FDA classification

FDA Class 1 ·Chromatography Separation/Zimmerman 17-Ketogenic Steroids

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

Cutaneous Tissue Adhesive With Mesh

FDA classification

FDA Class 2 ·Cutaneous Tissue Adhesive With Mesh

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

Tape And Bandage, Adhesive, Adjustable Closing Mechanism, Otc Use

FDA classification

FDA Class 1 ·Tape And Bandage, Adhesive, Adjustable Closing Mechanism, Otc Use

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