17 results
·
7ms
·
Sources: EU EUDAMED, US FDA
Braf Mutation Kit
FDA classification
FDA Not Classified
·Braf Mutation Kit
Tissue Processing Kit
FDA classification
FDA Not Classified
·Tissue Processing Kit
Kit, Cord Blood Collection
FDA classification
FDA Not Classified
·Kit, Cord Blood Collection
Kit, Cell Screening, Fetal
FDA classification
FDA Not Classified
·Kit, Cell Screening, Fetal
Burn Kit With Drug
FDA classification
FDA Not Classified
·Burn Kit With Drug
First Aid Kit With Drug
FDA classification
FDA Not Classified
·First Aid Kit With Drug
Ldt, Approved By Nys Clep
FDA classification
FDA Not Classified
·Ldt, Approved By Nys Clep
Kit, Western Blot, Hiv-1
FDA classification
FDA Not Classified
·Kit, Western Blot, Hiv-1
Multiple Osteoarticular Pathogen Antigen Kit
FDA classification
FDA Not Classified
·Multiple Osteoarticular Pathogen Antigen Kit
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
Kit, Test, Quality Control For Endotoxin
FDA classification
FDA Not Classified
·Kit, Test, Quality Control For Endotoxin
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
Covid-19 Test Home Collection Kit Devices
FDA classification
FDA Not Classified
·Covid-19 Test Home Collection Kit Devices
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