14 results · 19ms · Sources: EU EUDAMED, US FDA

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Ldt, Approved By Nys Clep

FDA classification
FDA Not Classified ·Ldt, Approved By Nys Clep

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

Ldt, Unmet Need Within An Integrated Healthcare System

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

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

Hemagglutination, Opiates

FDA classification
FDA Class 2 ·Hemagglutination, Opiates

Lipase Hydrolysis/Glycerol Kinase Enzyme, Triglycerides

FDA classification
FDA Class 1 ·Lipase Hydrolysis/Glycerol Kinase Enzyme, Triglycerides

Alpha-2-Macroglobulin, Rhodamine, Antigen, Antiserum, Control

FDA classification
FDA Class 2 ·Alpha-2-Macroglobulin, Rhodamine, Antigen, Antiserum, Control

Ldl & Vldl Precipitation, Hdl

FDA classification
FDA Class 1 ·Ldl & Vldl Precipitation, Hdl

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

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

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)