12 results · 19ms · Sources: EU EUDAMED, US FDA

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, Approved By Nys Clep

FDA classification
FDA Not Classified ·Ldt, Approved By Nys Clep

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

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

Laser Rangefinders, Time-Of-Flight Speed Measurement Products

FDA classification
FDA Not Classified ·Laser Rangefinders, Time-Of-Flight Speed Measurement Products

Test, Qualitative, Detection Of Dengue Igm And Igg Antibodies

FDA classification
FDA Not Classified ·Test, Qualitative, Detection Of Dengue Igm And Igg Antibodies

Extracorporeal System For Carbon Dioxide Removal For The Treatment Of Covid-19

FDA classification
FDA Not Classified ·Extracorporeal System For Carbon Dioxide Removal For The Treatment Of Covid-19

System, Intravaginal, For Controlled Release Of Drug Substance, Cder Or Cber Led

FDA classification
FDA Not Classified ·System, Intravaginal, For Controlled Release Of Drug Substance, Cder Or Cber Led

Barrier Face Covering Within The Scope Of The Face Mask And Barrier Face Covering Enforcement Policy

FDA classification
FDA Not Classified ·Barrier Face Covering Within The Scope Of The Face Mask And Barrier Face Covering Enforcement Policy

Face Mask Within The Scope Of The Face Mask And Barrier Face Covering Enforcement Policy Or Face Mask Umbrella Eua

FDA classification
FDA Not Classified ·Face Mask Within The Scope Of The Face Mask And Barrier Face Covering Enforcement Policy Or Face Mask Umbrella Eua