Phenotypic Test Kit, Non-Susceptible/Elevated Mic Organisms, Cultured Isolates

FDA classification

FDA Class 2 ·Phenotypic Test Kit, Non-Susceptible/Elevated Mic Organisms, Cultured Isolates

Assay, Enzyme Linked Immunosorbent, Hepatitis C Virus

FDA Pre-Market Approval

FDA Class 2 ·LIAISON XL MUREX HCV Ab; LIAISON XL MUREX Control HCV Ab

Prognostic Test For Assessment Of Liver Related Disease Progression

FDA classification

FDA Class 2 ·Prognostic Test For Assessment Of Liver Related Disease Progression

Suntan Lamp

FDA classification

FDA Class 2 ·Suntan Lamp

Digital Therapeutic Software For Attention Deficit Hyperactivity Disorder

FDA classification

FDA Class 2 ·Digital Therapeutic Software For Attention Deficit Hyperactivity Disorder

Prosthesis, Knee, Femorotibial, Unicompartmental/Unicondylar, Uncemented, Porous-Coated, Metal/Polymer

FDA classification

FDA Class 2 ·Prosthesis, Knee, Femorotibial, Unicompartmental/Unicondylar, Uncemented, Porous-Coated, Metal/Polymer

Suntan Bed

FDA classification

FDA Class 2 ·Suntan Bed

Prosthesis, Knee Patellofemorotibial, Partial, Semi-Constrained, Cemented, Polymer/Metal/Polymer

FDA classification

FDA Class 2 ·Prosthesis, Knee Patellofemorotibial, Partial, Semi-Constrained, Cemented, Polymer/Metal/Polymer

Ear, Nose, And Throat Stereotaxic Instrument

FDA classification

FDA Class 2 ·Ear, Nose, And Throat Stereotaxic Instrument

Diabetes Digital Therapeutic Device

FDA classification

FDA Class 2 ·Diabetes Digital Therapeutic Device

Prognostic Test For Development Or Progression Of Preeclampsia

FDA classification

FDA Class 2 ·Prognostic Test For Development Or Progression Of Preeclampsia

Intravenous Catheter Force-Activated Separation Device.

FDA classification

FDA Class 2 ·Intravenous Catheter Force-Activated Separation Device.

Liver Iron Concentration Imaging Companion Diagnostic For Deferasirox

FDA classification

FDA Class 2 ·Liver Iron Concentration Imaging Companion Diagnostic For Deferasirox

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

Test, Methadone, Employment And Insurance Testing, Exempt

FDA classification

FDA Class 2 ·Test, Methadone, Employment And Insurance Testing, Exempt

Test, Tricyclic Antidepressant Drugs, Employment And Insurance Testing, Exempt

FDA classification

FDA Class 2 ·Test, Tricyclic Antidepressant Drugs, Employment And Insurance Testing, Exempt

Test, Opiates, Employment And Insurance Testing, Exempt

FDA classification

FDA Class 2 ·Test, Opiates, Employment And Insurance Testing, Exempt

Test, Codeine, Employment And Insurance Testing, Exempt

FDA classification

FDA Class 2 ·Test, Codeine, Employment And Insurance Testing, Exempt

Test, Methaqualone, Employment And Insurance Testing, Exempt

FDA classification

FDA Class 2 ·Test, Methaqualone, Employment And Insurance Testing, Exempt

Test, Amphetamine, Employment And Insurance Testing, Exempt

FDA classification

FDA Class 2 ·Test, Amphetamine, Employment And Insurance Testing, Exempt