C. Difficile Toxin Gene Amplification Assay

FDA classification

FDA Class 2 ·C. Difficile Toxin Gene Amplification Assay

ß-Glucocerebrosidase (Gba) Newborn Screening Test System

FDA classification

FDA Class 2 ·ß-Glucocerebrosidase (Gba) Newborn Screening Test System

Filler, Bone Void, Alterable Compound For Cranioplasty

FDA classification

FDA Class 2 ·Filler, Bone Void, Alterable Compound For Cranioplasty

Electrical Tongue Stimulator To Treat Motor Deficits

FDA classification

FDA Class 2 ·Electrical Tongue Stimulator To Treat Motor Deficits

Computerized Behavioral Therapy Device For Treating Symptoms

FDA classification

FDA Class 2 ·Computerized Behavioral Therapy Device For Treating Symptoms

Ingestible Event Marker

FDA classification

FDA Class 2 ·Ingestible Event Marker

Alpha-D-Glucosidase (Gaa) Newborn Screening Test System

FDA classification

FDA Class 2 ·Alpha-D-Glucosidase (Gaa) Newborn Screening Test System

Endoscopic Access Overtube, Gastroenterology-Urology

FDA classification

FDA Class 2 ·Endoscopic Access Overtube, Gastroenterology-Urology

Antimicrobial Drapes

FDA classification

FDA Class 2 ·Antimicrobial Drapes

Peripheral Blood Processing Device For Wound Management

FDA classification

FDA Class 2 ·Peripheral Blood Processing Device For Wound Management

Magnetically Maneuvered Capsule Endoscopy System

FDA classification

FDA Class 2 ·Magnetically Maneuvered Capsule Endoscopy System

Coccidioides Spp. Nucleic Acid Detection System For Respiratory Specimens

FDA classification

FDA Class 2 ·Coccidioides Spp. Nucleic Acid Detection System For Respiratory Specimens

Digital Cervical Cytology Slide Imaging System With Artificial Intelligence Algorithm

FDA classification

FDA Class 2 ·Digital Cervical Cytology Slide Imaging System With Artificial Intelligence Algorithm

Prosthesis, Eyelid Spacer/Graft, Polymer

FDA classification

FDA Class 2 ·Prosthesis, Eyelid Spacer/Graft, Polymer

Alpha-L-Iduronidase (Idua) Newborn Screening Test System

FDA classification

FDA Class 2 ·Alpha-L-Iduronidase (Idua) Newborn Screening Test System

Endoscope, Accessories, Image Post-Processing For Color Enhancement

FDA classification

FDA Class 2 ·Endoscope, Accessories, Image Post-Processing For Color Enhancement

Alpha-D-Galactosidase A (Gla) Newborn Screening Test System

FDA classification

FDA Class 2 ·Alpha-D-Galactosidase A (Gla) Newborn Screening Test System

Cream, Nasal, Topical, Mechanical Allergen Particle Barrier

FDA classification

FDA Class 2 ·Cream, Nasal, Topical, Mechanical Allergen Particle Barrier

Plasmodium Spp. Detection Reagents

FDA classification

FDA Class 2 ·Plasmodium Spp. Detection Reagents

Anti-Ss-A 52 Autoantibodies

FDA classification

FDA Class 2 ·Anti-Ss-A 52 Autoantibodies