11 results · 41ms · Sources: EU EUDAMED, US FDA

Staphylococcus Aureus Somatic Antigens

FDA classification
FDA Class 1 ·Staphylococcus Aureus Somatic Antigens

Electrophoretic Method, Catecholamines

FDA classification
FDA Class 1 ·Electrophoretic Method, Catecholamines

Set, Gavage, Infant, Sterile

FDA classification
FDA Class 2 ·Set, Gavage, Infant, Sterile

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 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

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

Test, Luteinizing Hormone (Lh), Over The Counter

FDA classification
FDA Class 1 ·Test, Luteinizing Hormone (Lh), Over The Counter