| SCE — Ivd Offered As Ldt, First Marketed Before May 6, 2024, Not Modified Beyond Scope Described In Preamble To Ldt Final Rule | Class N / CH |
| SCF — Ldt, Unmet Need Within An Integrated Healthcare System | Class N / CH |
| SCG — Modified Version Of Another ManufacturerS Fda-Authorized Test Within Scope Described In Preamble To Ldt Final Rule | Class N / CH |
| SCH — Ldt, Approved By Nys Clep | Class N / CH |
| SCI — Ivd Offered As Ldt, Not An Ldt Or Under A Targeted Enforcement Discretion Policy Described In Preamble To Ldt Final Rule | Class N / CH |
| SCJ — Ldt, Not Under A Targeted Enforcement Discretion Policy Described In Preamble To Ldt Final Rule | Class N / CH |
| SCK — Ldt, Non-Molecular Antisera For Rare Rbc Antigens When There Is No Alternative Ivd | Class N / HE |
| SCL — Allergen And Vaccine Delivery Needles | Class 2 / HO |
| SCN — Temporarily Implanted Peripheral Nerve Stimulation System For Sustained Pain Relief | Class 2 / NE |
| SCP — Computerized Behavioral Therapy Device For Anxiety Disorders | Class 2 / NE |
| SCR — Air-Conduction Hearing Aid Software | Class 2 / EN |
| SCS — Ultraviolet Radiation Disinfection Chamber Device | Class 2 / HO |
| SCT — Foley Catheters And Accessories With Additional Safety Features | Class 2 / GU |
| SCU — Dna And Rna Oncology Controls | Class 2 / MG |
| SCV — Modular Electromechanical Surgical System | Class 2 / SU |
| SCW — Digital Prismatic Correction | Class 1 / OP |
| SCX — Immunoassay For Host Biomarkers Of Sepsis | Class 2 / MI |
| SCY — Sacroiliac Joint Guidewire Placement Device | Class 2 / OR |
| SCZ — Percutaneous Catheter For Cutting Or Splitting Heart Valve Leaflets Concomitant To Transcatheter Valve Procedures | Class 2 / CV |
| SDA — Electrical Tumor Treatment Fields For Non-Small Cell Lung Cancer | Class 3 / AN |
| SDB — Tracheal Prosthesis With Cover Material Derived From Human Sources | Class 2 / AN |
| SDC — Qualitative Cleaning Process Protein Indicator | Class 2 / HO |
| SDD — Electromechanical Surgical System Wherein The Surgeon Annd The User Interface Can Be In The Sterile Field | Class 2 / SU |
| SDE — Light Based Device For Dry Age-Related Macular Degeneration | Class 2 / OP |
| SDG — Brain Intraparenchymal Infusion Cannula | Class 2 / NE |
| SDJ — Adjunctive Cardiac Amyloidosis Status Indicator | Class 2 / CV |
| SDK — Transdermal Test For Assessment Of Glomerular Filtration Rate | Class 3 / GU |
| SDL — Transvenous Temporary Phrenic Nerve Stimulator | Class 3 / AN |
| SDM — Nucleic Acid Test Used For Screening Of Cadaveric (Non-Heart-Beating) Donors Of Blood Or Blood Products Or Hct/Ps | Class U / MI |
| SDN — Serology Test Used For Screening Of Cadaveric (Non-Heart-Beating) Donors Of Blood Or Blood Products Or Hct/Ps | Class U / MI |
| SDO — Transcutaneous Electrical Spine Stimulator To Improve Skeletal Muscle Strength And Sensation | Class 2 / PM |
| SDP — Kappa And Lambda Immunoglobulin Light Chain In Situ Hybridization Mrna Probe Detection Kit | Class 2 / MG |
| SDQ — Alfapump System | Class 3 / GU |
| SDS — Compression-Based Airway Clearance Device | Class 2 / AN |
| SDT — Intra-Pulmonary Percussive Vibration (Ipv) Devices | Class 2 / AN |
| SDV — Clinical Electronic Thermometer | Class 2 / HO |
| SDW — Stationary Infrared Thermometer | Class 2 / HO |
| SDX — Neuromuscular Stimulator And Exercise Evaluation System | Class 2 / NE |
| SDY — Loss Of Pulse Notification Software | Class 2 / CV |
| SDZ — Endovascular System For Treatment Of Ascending Aorta And Aortic Arch Lesions | Class 3 / CV |
| SEA — Test For Detection Of Microorganism(S) Causing Sexually Transmitted Infections Performed By Lay Users | Class 2 / MI |
| SEC — Wearable Fall Injury Prevention Device | Class 2 / PM |
| SEE — Computerized Behavioral Therapy Device For Migraine | Class 2 / NE |
| SEF — Central Venous Catheter With Manual Insertion System | Class 2 / HO |
| SEG — Leadless Cardiac Resynchronization Therapy (Crt) | Class 3 / CV |
| SEI — Qualitative And Quantitative Hepatitis B Virus Antibody Assays | Class 2 / MI |
| SEJ — Wound Dressings Containing Topical Analgesics | Class U / SU |
| SEK — Wound Dressings With Hydrocortisone | Class U / SU |
| SEL — Securement Wound Dressing For Reduction Of Infection | Class U / SU |
| SEM — Sub-Scalp Implanted Electroencephalogram System For Remote Patient Monitoring | Class 2 / NE |