System, Test, Her-2/Neu, Nucleic Acid Or Serum

FDA classification

FDA Class 3 ·System, Test, Her-2/Neu, Nucleic Acid Or Serum

Dvd, Dvd-Rom, Bluray, Hd Player

FDA classification

FDA Not Classified ·Dvd, Dvd-Rom, Bluray, Hd Player

Dvd, Bluray, Or Hd Recorder

FDA classification

FDA Not Classified ·Dvd, Bluray, Or Hd Recorder

Mid-Stream Collection Kit

FDA classification

FDA Class 1 ·Mid-Stream Collection Kit

Prosthesis, Knee, Patello/Femorotibial, Unconstrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer

FDA classification

FDA Class 3 ·Prosthesis, Knee, Patello/Femorotibial, Unconstrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer

Catheter, Percutaneous (Valvuloplasty)

FDA classification

FDA Class 3 ·Catheter, Percutaneous (Valvuloplasty)

Calibrator For Alpha-Fetoprotein In Mid-Pregnancy Maternal Serum

FDA classification

FDA Class 3 ·Calibrator For Alpha-Fetoprotein In Mid-Pregnancy Maternal Serum

Joint Biological Agent Identification And Diagnostic System (Jbaids) Tularemia Detection Kit

FDA classification

FDA Class 2 ·Joint Biological Agent Identification And Diagnostic System (Jbaids) Tularemia Detection Kit

Electroconvulsive Therapy Device For Catatonia, Major Depressive Disorder, And Bipolar Disorder

FDA classification

FDA Class 2 ·Electroconvulsive Therapy Device For Catatonia, Major Depressive Disorder, And Bipolar Disorder

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

Ngs Whole Genome Sequencing For Sars-Cov-2 Genetic Analysis

FDA classification

FDA Not Classified ·Ngs Whole Genome Sequencing For Sars-Cov-2 Genetic Analysis

Methicillin Resistant Staphylococcus Aureus/Methicillin Susceptible Staphylococcus Aureus Blood Culture Test Bt

FDA classification

FDA Class 1 ·Methicillin Resistant Staphylococcus Aureus/Methicillin Susceptible Staphylococcus Aureus Blood Culture Test Bt

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

Covid-19 Test Home Collection Kit Devices

FDA classification

FDA Not Classified ·Covid-19 Test Home Collection Kit Devices

Immunohistochemical Assay, Helicobacter Pylori

FDA classification

FDA Class 1 ·Immunohistochemical Assay, Helicobacter Pylori

High Throughput Dna Sequencing For Hereditary Cancer Predisposition Assessment Test System.

FDA classification

FDA Class 2 ·High Throughput Dna Sequencing For Hereditary Cancer Predisposition Assessment Test System.

General Purpose Reagent

FDA classification

FDA Class 1 ·General Purpose Reagent