10 results
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37ms
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Sources: EU EUDAMED, US FDA
Filters
FDA Classification
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Port & Catheter, Implanted, Subcutaneous, Intravascular
FDA classification
FDA Class 2
·Port & Catheter, Implanted, Subcutaneous, Intravascular
Alloy, Gold-Based Noble Metal
FDA classification
FDA Class 2
·Alloy, Gold-Based Noble Metal
Hydrazone Colorimetry, Aldolase
FDA classification
FDA Class 1
·Hydrazone Colorimetry, Aldolase
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
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