11 results
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44ms
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Sources: EU EUDAMED, US FDA
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FDA Classification
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Shoe With Adjustable Sole Units
FDA classification
FDA Class 1
·Shoe With Adjustable Sole Units
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
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
Modified Version Of Another ManufacturerS Fda-Authorized Test Within Scope Described In Preamble To Ldt Final Rule
FDA classification
FDA Not Classified
·Modified Version Of Another ManufacturerS Fda-Authorized Test Within Scope 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
Remote Or Wearable Patient Monitoring Device For Drug Induced Qt Prolongation Monitoring
FDA classification
FDA Not Classified
·Remote Or Wearable Patient Monitoring Device For Drug Induced Qt Prolongation Monitoring
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