14 results
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16ms
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Sources: EU EUDAMED, US FDA
Filters
FDA Classification
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Diazo, Alt/Sgpt
FDA classification
FDA Class 1
·Diazo, Alt/Sgpt
Vanillin Pyruvate, Alt/Sgpt
FDA classification
FDA Class 1
·Vanillin Pyruvate, Alt/Sgpt
Hydrazone Colorimetry, Alt/Sgpt
FDA classification
FDA Class 1
·Hydrazone Colorimetry, Alt/Sgpt
Preamplifier, Ac-Powered, Ophthalmic
FDA classification
FDA Class 2
·Preamplifier, Ac-Powered, Ophthalmic
Hemagglutination, Opiates
FDA classification
FDA Class 2
·Hemagglutination, Opiates
Adaptor, Recreational
FDA classification
FDA Class 1
·Adaptor, Recreational
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
Nadh Oxidation/Nad Reduction, Alt/Sgpt
FDA classification
FDA Class 1
·Nadh Oxidation/Nad Reduction, Alt/Sgpt
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 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