17 results · 7ms · Sources: EU EUDAMED, US FDA

Get notified when this changes

We'll email you when new records match this search — new devices, new clearances, certificate changes, or withdrawals.

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 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