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

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

High Throughput Sequencing Based Tumor Profiling Test Of Circulating Cell-Free Nucleic Acids

FDA classification

FDA Class 2 ·High Throughput Sequencing Based Tumor Profiling Test Of Circulating Cell-Free Nucleic Acids

Adhesive Backed Thermal Skin Patches

FDA classification

FDA Class 1 ·Adhesive Backed Thermal Skin Patches

Filler, Recombinant Human Bone Morphogenetic Protein, Collagen Scaffold, Osteoinduction - Hde

FDA classification

Filler, Recombinant Human Bone Morphogenetic Protein, Collagen Scaffold, Osteoinduction - Hde

Calcium Salt Bone Void Filler, Drillable, Non-Screw Augmentation

FDA classification

FDA Class 2 ·Calcium Salt Bone Void Filler, Drillable, Non-Screw Augmentation

Physiological Signal Based Seizure Monitoring System

FDA classification

FDA Class 2 ·Physiological Signal Based Seizure Monitoring System

Crimper, Wire, Ent, Non-Sterile

FDA classification

FDA Class 1 ·Crimper, Wire, Ent, Non-Sterile

Digital Image, Storage And Communications, Non-Diagnostic, Laboratory Information System

FDA classification

FDA Class 1 ·Digital Image, Storage And Communications, Non-Diagnostic, Laboratory Information System

Tumor Gene Profiling Test

FDA classification

FDA Not Classified ·Tumor Gene Profiling Test

Denture, Cosmetic Only

FDA classification

FDA Not Classified ·Denture, Cosmetic Only

Mitral Valve Repair Devices

FDA classification

FDA Class 3 ·Mitral Valve Repair Devices

Software-Aided Adjunctive Diagnostic Device For Use By Physicians On Lesions Suspicious For Skin Cancer

FDA classification

FDA Class 2 ·Software-Aided Adjunctive Diagnostic Device For Use By Physicians On Lesions Suspicious For Skin Cancer

Adult Portable Bed Rails For Medical Purposes

FDA classification

FDA Class 1 ·Adult Portable Bed Rails For Medical Purposes

Vessel Guard Or Cover

FDA classification

FDA Class 2 ·Vessel Guard Or Cover

Anti-Theft Detector (Non-Eas)

FDA classification

FDA Not Classified ·Anti-Theft Detector (Non-Eas)

Opioid Use Disorder Genetic Risk Variant Detection System And Collection Kit

FDA classification

FDA Class 3 ·Opioid Use Disorder Genetic Risk Variant Detection System And Collection Kit

Ataxiagraph

FDA classification

FDA Class 1 ·Ataxiagraph

Saline, Vascular Access Flush

FDA classification

FDA Class 2 ·Saline, Vascular Access Flush

Heparin, Vascular Access Flush

FDA classification

FDA Class 2 ·Heparin, Vascular Access Flush