15 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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Instrumentation, High Pressure Liquid Chromatography
FDA classification
FDA Class 1
·Instrumentation, High Pressure Liquid Chromatography
Low-Density Lipoprotein (Ldl) Cholesterol Sub-Fraction Test
FDA classification
FDA Class 1
·Low-Density Lipoprotein (Ldl) Cholesterol Sub-Fraction Test
Diazonium Colorimetry, Urobilinogen (Urinary, Non-Quant.)
FDA classification
FDA Class 1
·Diazonium Colorimetry, Urobilinogen (Urinary, Non-Quant.)
Needle, Aspiration And Injection, Reusable
FDA classification
FDA Class 1
·Needle, Aspiration And Injection, Reusable
Ldt, Approved By Nys Clep
FDA classification
FDA Not Classified
·Ldt, Approved By Nys Clep
Ldl & Vldl Precipitation, Hdl
FDA classification
FDA Class 1
·Ldl & Vldl Precipitation, Hdl
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
Enzyme Linked Immunosorbent Assay For The Detection Of Lipoarabinomannan Antigen Of Mycobacteria
FDA classification
FDA Not Classified
·Enzyme Linked Immunosorbent Assay For The Detection Of Lipoarabinomannan Antigen Of Mycobacteria
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
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)
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