12 results
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40ms
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Sources: EU EUDAMED, US FDA
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FDA Classification
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System, Test, Urinary Methylmalonic Acid
FDA classification
FDA Class 2
·System, Test, Urinary Methylmalonic Acid
Probe, Blood-Flow, Extravascular
FDA classification
FDA Class 2
·Probe, Blood-Flow, Extravascular
Microscope, Surgical
FDA classification
FDA Class 1
·Microscope, Surgical
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
External Upper Esophageal Sphincter (Ues) Compression Device
FDA classification
FDA Class 2
·External Upper Esophageal Sphincter (Ues) Compression Device
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
Auto-Antibodies; Phosphatidylserine, Prothrombin, Phosphatidylserine/Prothrombin Complex
FDA classification
FDA Class 2
·Auto-Antibodies; Phosphatidylserine, Prothrombin, Phosphatidylserine/Prothrombin Complex
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