14 results · 16ms · Sources: EU EUDAMED, US FDA

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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 Manufacturer’S Fda-Authorized Test Within Scope Described In Preamble To Ldt Final Rule

FDA classification
FDA Not Classified ·Modified Version Of Another Manufacturer’S Fda-Authorized Test Within Scope Described In Preamble To Ldt Final Rule